Application for the Use of Human Subjects
Part A Application Information (Only typed applications will be reviewed; submit 2, unstapled copies to ORCA in A-285 ASB)
| Title of the Study: Impact of Physical Activity on Components of Physical Fitness: A Comparative Cross-Cultural Study of Schoolchildren in the United States, Ghana, and Mexico 1. | |||
| 2. Principal Investigator: Barbara Simmons | 3. Contact Person: (if different from PI) | ||
| Title: Undergraduate | Dept: Exercise Sciences | Title: | Dept: |
| Address (+ ZIP): 996 S 650 W | Address (+ Zip): | ||
| Phone: 801.358.5479 | Email: barbara.simmons27@gmail.com | Phone: | Email: |
| 4. Co-Investigator(s): (Name & Affiliation) Ulrike Mitchell PhD, PT, A. Wayne Johnson PhD, PT of the Exercise Sciences, Brigham Young University | |||
| 5. Research Originated By: (Check One) X Faculty Student Staff | |||
| 6. Research Purpose(Check All that Apply): Grant Dissertation Thesis ORCA Scholarship Honors Thesis Course Project: Which Course? _________ | |||
| 7. Correspondence Request: Mail X Call for Pick-Up> | |||
Part B Research Study Synopsis
| 1. Brief Study Description (Include Purpose of the Research): This project is part of a cross-sectional study which will compare posture, core strength, body composition, activity level and functional movement between individuals of various cultures and geographic locations. High income countries around the world have experienced dramatic increases in obesity and sedentary behaviors in: both genders, all income levels and ethnic groups, and all ages.[1] There is an expected increase in musculoskeletal and cardio-respiratory disorders manifested by excess sedentary behavior, poor posture, obesity, and low fitness. The purpose of this study will be to correlate physical activity, posture, body composition, core strength and functional movement in communities around the world. This particular project will be conducted in the rural villages (ranchos residing outside of Irapuato Mexico. Data will be collected as explained within the body of this proposal and then will be compared to similar studies conducted in other locations throughout the world. |
| 2. Study Length What is the duration of the study? 5/11-8/11 (in-field) 8/11- 12/11 (analysis and write-up) |
| 3. Location of Research a. Where will the research take place? Ranchos outside of Irapuato, Guanajuato, Mexico b. Will the PI be conducting and/or supervising research activity off-campus? X Yes No If Yes, please list sites: public schools and homes in villages outside of Irapuato Mexico |
| 4. Subject Information: a. Number of Subjects: 25-35 b. Gender of Subjects: Male and Female c. Ages of Subjects: 10-13 |
| 5. Potentially Vulnerable Populations: (Check All that Apply) X Children Pregnant Women Cognitively Impaired Prisoners Institutionalized Faculty’s Own Students Other. Please describe: |
| 6. Non-English Speaking Subjects a. Will subjects who do not understand English participate in the research: Yes X No b. If yes, describe your resources to communicate with the subjects: I am fluent in Spanish and as well I will show subjects a film in Spanish demonstrating the exercises that the children will complete for the study. c. Into what language(s) will the consent form be translated: Spanish |
| 7. Additional Subject Concerns a. Are there cultural attitudes/beliefs that may affect subjects in this study? X Yes No b. If yes, please describe attitudes and how they may affect subjects. While this topic is not culturally sensitive I realize that it is a different culture with different ideas of the subject and I will need to adjust my procedures and behavior accordingly. |
| 8. Dissemination of Research Findings a. Will the research be published? X Yes No If yes, where if known? Inquiry Journal at BYU as well this research will likely be submitted to BMC Musculoskeletal Disorders b. Will the research be presented? X Yes No If yes, where if known? Inquiry Conference at BYU |
| 9. External Funding a. Are you seeking external funding? Yes X No What agency? b. Have you received funding? Yes X No c. Dollar amount? |
| 10. Method of Recruitment: (Check All that Apply) Flyer X Classroom Announcement Letter to Subjects Third Party Random Other: Convenience Sampling |
| 11. Payment to Subjects a. Will subjects be compensated for participation? X Yes No If yes, please indicate amount: b. Form of Payment: Cash Check Gift Certificate Voucher 1099 Other: small toys for the participants (Note: this is a method of compensation that was used in a previous study. I am not sure whether this is appropriate for the location and culture of my study. I have an appointment to speak to a Mexican this week to discuss what would be the most appropriate method of compensation.) c. Will Payment be prorated? Yes X No If yes, please explain: d. When will the subject be paid? Each Visit X Study Completion Other |
| 12. Extra Credit a. Will subjects be offered extra credit? Yes X No b. If yes, describe the alternative: |
| 13. Risks: Identify all potential risks/discomforts to subjects. As with any fitness testing there may be some discomfort for participants when attempting to perform an exercise that they are not used to or that might be somewhat difficult. However, for these stability exercises load amount is very low so there is minimal risk or injury. Subjects will be asked to stand in their normal standing posture which presents no additional risk to the subject. Subjects will be asked to perform functional movement screen and strength tests; there is a very minimal risk associated with these activities. If the subject feels they cannot do the activities or feel uncomfortable they may stop participation. If injury occurs the subject will be asked to seek local medical care. |
| 14. Benefits: a. Are there direct benefits to participants? Yes X No If yes, please list. b. Are there potential benefits to society? Yes No If yes, please list. With the information gathered from this study we will compile it and into a larger study in order to compare the data and results. We will then be better informed of the types, durations, and intensities of activities that promote better musculoskeletal health and how they are influenced by differences in various populations. |
| 15. Study Procedures (DO NOT LEAVE ANY ITEM BLANK): a. What will be the duration of the subjects’ participation? Subjects will have activity levels monitored for 5 days (and no more than 7) days for 22-23 hours per day. Questionnaires, posture assessment (photographs) and functional movement screening and strength tests will require approximately an hour on one day. b. Will the subjects be followed after their participation ends? Yes X No If yes, please describe: c. Describe the number, duration and nature of visits/encounters. Subjects will be given the accelerometer and instructed in its use. Subjects will wear an active graph accelerometer for 5 days and no more than 7 days for 22-23 hours per day during normal activity d. Is the study Therapeutic? X Non-therapeutic? e. List all procedures that will be performed to generate data for the research. · Subjects will wear an accelerometer to measure activity level. · Subjects will have posture assessment video/photographs taken of their normal standing posture from a posterior, lateral and anterior view. Subjects will move through their normal free range of motion and a video/photograph will be taken at end ranges.[2] · Subjects will fill out a pre-participation questionnaire · Subjects will perform functional strength tests (prone plank, side bridging, step down test, deep squat, hurdle step, inline lunge, shoulder mobility, active straight-leg raise, trunk stability push-up, rotary stability) · Body composition testing (calipers) · Participants will perform the Functional Movement Screen (see attached sheet in appendix) to assess their balance, strength, flexibility; this assessment will be filmed for later evaluation. (I need to clarify with my professors exactly what this entails- it may not be necessary for my particular study) f. List all procedures/questionnaires done solely for the purpose of the research study. · Subjects will wear an accelerometer to measure activity level. · Subjects will have posture assessment video/photographs taken of their normal standing posture from a posterior, lateral and anterior view. Subjects will move through their normal free range of motion and a photograph will be taken at end ranges. · Subjects will fill out a pre-participation questionnaire · Subjects will perform functional strength tests (prone plank, side bridging, step down test) · Participants will perform the Functional Movement Screen; this will be filmed. · Body composition testing (calipers) g. List all procedures/questionnaires participants already do regardless of research. While the participants do not usually wear a pedometer or accelerometer throughout the day, the purpose is to measure the activities that they do on a regular basis. They will be informed to perform the same activities that they normally would throughout the day. (I will be making observations and taking notes during the study as well as talking with or informally interviewing the people there. However, this data will be for my own in knowing how to most appropriately approach the study in this particular location as well as for course work for other classes. None of this information will be used within this study- meaning that the data collected in this will not be published or included in the resulting write-up. It still may be relevant to include it in this protocol- where should I put it and how would you suggest that I describe it?) |
| 16. Informed Consent: a. Are you requesting Waiver or Alteration of Informed Consent? X Yes No If yes, please fill out the waiver of informed consent and attach it. b. Briefly describe your process to obtain consent: I will explain the procedures of the study as well as the risks and benefits to the parents/guardians as well as the participants. The parents/guardians will then be given an IRB approved consent form to read and sign if they would like their child to participate in the study. The children will also be able to sign the IRB approved ascent form if they would like to participate. |
| 17. Confidentiality: a. Are the subject’s social security number, BYU ID number or any identifier (other than study number and initials) being sent off site? Yes X No If yes, describe and explain reasons: b. Will any entity other than the investigative staff have access to medical, health or psychological information about the subject? Yes X No If yes, please indicate who: c. Briefly describe provisions made to maintain confidentiality of data, including who will have access to raw data, what will be done with the tapes, where data will be stored, how long data will be stored, etc. Throughout the time spent in the field, I will be the only one with access to the data I collect. Participants will be identified only by a subject number generated for the study. No other personal information will be used to identify the participant. Data will be entered into a computer with password protection. Photographs will also be stored in the computer. Any notes or other information in a hard copy will be locked in a bag in my room where I will have sole access. Participant confidentiality will be maintained throughout. Data will only be reported as group data with no identifying information. Data will be stored for three years. d. Will raw data be made available to anyone other than the PI and immediate study personnel? Yes X No If yes, describe the procedure for sharing data. Include with whom it will be shared, how and why. |
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Part C
The attached investigation involves the use of human subjects. I understand the university’s policy concerning research involving human subjects and I agree:
1) X Yes No To obtain voluntary and informed consent of subjects who are to participate in this project.
2) X Yes No To report to the IRB any unanticipated effects on subjects which become apparent during the course of, or as a result of, the experimentation and the actions taken.
3) X Yes No To cooperate with members of the committee charged with continuing review of this project.
4) X Yes No To obtain prior approval from the committee before amending or altering the scope of the project or implementing changes in the approved consent document.
5) X Yes No To maintain the documentation of consent forms and progress reports as required by institutional policy.
6) X Yes No To safeguard the confidentiality of research subjects and the data collected when the approved level of research requires it.
Signature* of the Principal Investigator: Date:
*Faculty Sponsor Signature Required for All Student Submissions (will not be processed without this)
“I have read and reviewed this proposal and certify that it is ready for review by the IRB. I have worked with the student to prepare this research protocol. I agree to mentor the student during the research project.”
Faculty Sponsor (Please sign and print):
Required: Thesis/Dissertation – Date of Approval by the Proposal Review Committee:
Required: Committee Chair/Faculty Sponsor (Please sign and print):
_______________________________________________________
* If you are faculty submitting by email, please check this box to verify that you are the PI listed on this application and agree to follow the items listed above. I agree
Only professors can submit applications electronically via email.
Part D Synopsis of the Proposal—
1. Specific Aims
This project is part of a cross-sectional study which will compare posture, core strength, body composition, activity level and functional movement between individuals of various cultures and geographic locations. High income countries around the world have experienced dramatic increases in obesity and sedentary behaviors in: both genders, all income levels and ethnic groups, and all ages.[1] There is an expected increase in musculoskeletal and cardio-respiratory disorders manifested by excess sedentary behavior, poor posture, obesity, and low fitness. The purpose of this study will be to correlate physical activity, posture, body composition, core strength and functional movement in communities around the world. This particular project will be conducted in the rural villages (ranchos residing outside of Irapuato Mexico. Data will be collected as explained within the body of this proposal and then will be compared to similar studies conducted in other locations throughout the world.
2. Hypothesis or Research Question
While this study is solely a comparative study in order to relate physical activity with core stability in different regions of the world, we do hypothesize that activities of longer duration and greater intensities will promote greater core stability. These activities may include running and playing organized games like soccer. In addition, more time spent idle especially sitting or lying down with the back propped up against a chair or wall will result in poorer core stability. In brief, there will be significant differences in activity level, functional strength, and posture and body composition between individuals of different cultures and geographic regions.
3. Background and Significance
It is well known that obesity is becoming an epidemic throughout the world. Researchers continue to see a steady decline in physical activity among children and adolescents especially in the United States and more developed countries (Carlson, Fulton, Schoenborn, & Loustalot, 2010). The consequences include an increased incidence of obesity and diabetes in children. (National Center for Chronic Disease Prevention and Health Promotion, 2010.) We hypothesize that factors such as core strength, posture and body composition are also affected.
In recent years there has been a lot of emphasis placed on the importance of health and physical activity in the United States and throughout the world. Numerous types of studies have also emphasized the importance of spinal stability. Backpack load, for instance, has been a highlighted topic for school children for several years. Studies show that increased weight in backpacks causes spinal compression which can lead to serious back pain or injury. (Neuschwander) Many elementary school students in the United States have been affected by problems such as this. In addition, there has been an increased occurrence of sedentary lifestyle with the increase of television programs offering programs for younger viewers, as well as video games and other pass times that require little physical exertion. Children of the same age in rural Mexico do not have these types of idle activities available to them. Much of their time is spent running and playing organized games like soccer. In addition, walking is the primary mode of transportation in rural Mexico whereas in the United States most families own cars.
The culture of Mexico also calls for differences in activity levels within the public school systems. One study reported that during school in rural Mexico, children are more active in the classroom. They are not expected to remain seated throughout the day or while doing work. They are given the freedom to socialize and work with other students around the classroom. (Bryan) This differs significantly from schools in the United States where students are obliged to remain seated during instruction and work time. There have been some innovations within the classrooms of the United States in order to provide more opportunities for movement during class time. One example includes a standing desk that was created by a teacher after seeing her students shuffle and shift in their seats in class. The desks allow students to sit or stand and as such, allow for more movement during the day. This seems to mimic the liberty that students in rural Mexico are given to move around more during class time. (Saulny)
The United States has seen an increase in obesity in childhood as well as other chronic diseases that correlate with lack of physical activity. This is one area that Mexico seems to share. In recent studies regarding Mexico (note: these studies were not isolated to rural Mexico, where I will be conducting my research) children as well as adults are following the same obesity trends that exist within the United States. (Uauy) With an increase in BMI and a decrease in trunk stability comes an increased risk of injury and disease during childhood and in later adulthood. Within this same study, however, it is noted that those cultures that live off the land and are more isolated from larger cities do not share this same increase in obesity. The children with whom I will be working live in more rural communities and would be expected to have a lower BMI because of their increased activity level and therefore lower risk of the chronic diseases that would affect trunk stability.
4. Description of Subjects
The subjects will include 25-30 children ages 10-13. They will need parental/guardian approval and subject ascent. Both males and females will be included in the study. I will not exclude any participants based on race or ethnicity. Participants will need to have lived in the region for the last five years in order to ensure that they are well integrated into the culture and societal influences of physical activity similar to a native participant. Children of this age group are being used because “motor and sensory systems involved in postural stability [. . .] reach adult maturity by 7-10 years.” (Maureen) So their nervous system is fully developed for back and trunk support but they are still growing and their physical activity will largely determine whether they maintain good stability into their later years or whether they will be at an increased risk of pain and injury. I will recruit subjects through convenience sampling and snowball sampling. I will be living in the area and will integrate myself into the community in various ways. For example, I will volunteer as an aid in the local schools thereby enabling me to meet children of this age group. I will then send home letters to the parents explaining the study and asking to be able to meet with them to explain it to them. I will also make myself available to the work with and help the adults of the community in their daily tasks and in this way I will be able to meet people whose children may be able to participate in the study.
5. Confidentiality
During the study, data will be stored in a computer that is password protected. As well any digital photographs will also be stored in this computer. As well, identifiers will be eliminated and each subject will be given a number. The photographs will also be modified so that the participant’s face is unrecognizable. Other data, notes taken etc, will be kept in a storage compartment with a lock in my private room. Upon completion the data will be used only by me or my associated investigators to analyze the data. All data will be kept in the archives of the mentoring professor’s office but no identifiers will be kept. No video or audio footage will be acquired. No quotes will be used in research publications.
6. Method or Procedures
Participants or their guardians will read and sign an informed consent or ascent as appropriate.
Participants will do the following:
Wear an accelerometer or pedometer around the waist for 5 days (and no more than 7 days) to record activity level. Physical activity should be objectively measured every 5 s for five or seven consecutive days using ActiGraph accelerometers (7164 model; MTI Health Services, Florida, USA). The ActiGraph is a commonly used tool to assess the volume and intensity of physical activity, and it has been validated for use in paediatric and adult populations. The students will be asked to wear the ActiGraph over their right hip using a tight fitting elastic belt during all waking hours except during water-based activities and contact sports. After 5 or 7 days data collection the ActiGraphs will be downloaded using manufacturer software (Actisoft Analysis Software v. 3.2, MTI Health Services). Downloaded raw files were checked for compliance to the monitoring protocol using customized software (MAHUffe; www.mrc-epid.cam.ac.uk).
· Subjects will have posture assessment photographs taken of their normal standing posture from a posterior, lateral and anterior view. Reflective markers will be placed at boney landmarks to allow for consistent analysis of posture between participants. Two sided tape will be used to secure reflective markers to the participants.
· Participants will move through their normal free range of motion and a photograph will be taken at end ranges.
· Participants will fill out a pre-participation questionnaire
· Participants will perform functional strength tests (prone plank, side bridging, step down test). These tests will require the participants to hold the test position for as long a time as they feel they are able. The duration of the held position will be recorded.
· Participants will perform the Functional Movement Screen (see attached sheet in appendix) to assess their balance, strength, flexibility; this assessment will be filmed for later evaluation.[4]
· Body composition testing (calipers). Body fat calipers will be used to assess percent body fat; waist circumference will be measured.
7. Data Analysis
Qualitative data will be taken throughout the study through observation of types of physical activities engaged in throughout the day. Analysis will be done through comparing the different activities to find common themes within the activities.
Quantitative data will be analyzed through statistical measurements. These tests include but are not limited to descriptive data, such as ANOVA, t-tests, and chi-squared tests. Quantitative data will include the number of steps taken as recorded in the pedometer, as well as the activity levels and durations in different planes as recorded with the accelerometer. The various fitness tests will be scored by me based on the accuracy of position and strength capability of each participant. Age, gender, and race/ethnicity will also be considered to determine any significant correlations that may exist within these groups.
8. Risks
There will be minimal risks within my study. However, there are a few potential risks that I can foresee and will therefore take precautions to avoid. One possible risk is the liability of being alone with children. I will eliminate this risk by always inviting an adult (most likely a parent of the child) to be present with me while administering the tests. If I cannot find an adult I will administer the tests outside in a public setting, with other adults in the vicinity.
In addition there may be some physical risks to the participants during the fitness testing. Each test will be performed on a mat (which I will supply), not on a hard surface, to decrease the risk of injury if the subject falls. Also, I will clean the mat with a disinfectant cleaner upon completion of each individual’s test. None of the testing procedures with performed at a duration or intensity that the children do not experience on a regular basis.
9. Benefits
There are no direct benefits for participation in the study for participants.
Benefits to society include better information about the types, durations and intensities of activities that promote greater core stability in children. This information can be used by parents, caregivers, teachers, and health professionals as a way to instruct and encourage activities in children that will increase musculoskeletal health and decrease risk of injusry or pain. I plan to inform the participants of the study of the results in easily understood jargon so that they may be well informed of the types of activities that are most beneficial to them. In addition, I plan to prepare a publishable research article that will include the data from this study as well as data collected from the United States, Ghana, and Hungary. With the information presented in a scientific journal the research community will have access to the results of the study and be able to use the information for further research and development of health care procedures within their own communities.
10. Compensation
To express gratitude for their cooperation and willingness to help me in this research, I will offer participants a small gift. For the children I will give them a small toy that I will bring from the United States. Each toy will be the same so there are no feelings of jealousy and will cost no more than $3.00. For the parents and any other adults that help me with the study, I will give a small gift most likely in the form of foodstuff or another appropriate gift depending on the culture. Gifts will be given at the completion of each participants testing. (Again, I am not sure if this is appropriate for the area that I will be in but I will find out and change my plan accordingly.)
11. References
McEvoy, M, & Grimmer, K. (2005). Reliability of upright posture measurements in primary school children. BMC Musculoskeletal Disorders, 6(35), Retrieved from www.biomedcentral.com/1471-2474/6/35 doi: 10.1186/1471-2474-6-35
National Center for Chronic Disease Prevention and Health Promotion, (2010, June 03). Childhood obesity. Retrieved from http://www.cdc.gov/HealthyYouth/obesity/
Carlson, S, Fulton, J, Schoenborn, C, & Loustalot, F. (2010). Trend and prevalence estimates based on the 2008 physical activity guidelines for americans. American Journal of Preventative Medicine 39(4), 305-313.
Adams, J. (2006). Trends in physical activity and inactivity amongst us 14-18 year olds by gender, school grade and race, 1993-2003: evidence from the youth risk behavior survey. BMC Public Health, 6(57), 1-7.
12. Qualifications
I am currently a senior at BYU studying Exercise Science and preparing for physical therapy school. Most of my classes focus on the physiological and functional workings of the body. I have completed functional anatomy, exercise physiology, kinesiology, and other specialized classes as well as coursework in statistics, psychology, and ethical considerations in exercise science that will be applied to this study. I am also currently working as an intern in a physical therapy clinic in Provo Utah where I am able to work directly with patients teaching them different exercises in order to improve their health.
I also have experience working with children. As a karate teacher for over three years, I instructed both children (from age 2 up) and adults in the specific stances and positions that were required for correct performance and physical stability. I learned to adapt my teachings based on each student’s particular developmental stages. I routinely instructed them in games and other activities which allowed them to develop their skills and their trust in me, which I hope to accomplish as an aid in the schools in Mexico.
I have experience outside the US. I lived in France and Switzerland for 18 months where I communicated mostly in French but occasionally in Spanish. I continued my studies in Spanish at BYU and am conversationally fluent in that language.
My mentor, Ulrike Mitchell, is a certified Physical Therapist and has practiced physical therapy for over 20 years. She is now an assistant professor in the Exercise Sciences department. She has been working with Dr. Wayne Johnson of the Exercise Science department on this project for several months. Dr. Johnson was the primary faculty mentor for this same project that was conducted in Ghana in 2009. Together they have over 50 years of physical therapy experience as well as numerous years of research experience in the physical therapy field.
Include the following information as necessary in the appropriate appendix.
Appendix E – Consent Document or
Request for a Waiver and/or Alteration of Informed Consent:
On the Consent Form. Indicate the number of pages and an area for initials: For example, page 1 of 2 _____ (initials).
Cross-cultural comparison of posture, physical activity, body composition and muscle strength: Comparison of individuals from around the World
Consent to be a Research Subject (Consent for Child by Guardian)
Introduction
This research study is being conducted by Martina Uvacsek, PhD, Dr. Miklos Toth MD, PhD, DSc, and Ramocsa Gabor, from Semmelweis Egyetem, Hungary; and, Wayne Johnson PhD, PT, Ulrike Mitchell PhD, PT and. Bill Myrer PhD, from Brigham Young University. We want to determine the relationship between posture, physical activity, body composition, and muscle strength. You or your child is invited to participate because you have responded to the announcement of the study.
In red are the people that Dr. Johnson will be working with in Hungary- I assume that I don’t really need to put their names in this consent form but I wanted to check. Also I will put my name in.
Procedures
You or your child will first fill out the pre-participation questionnaire. This includes information about your child, including age, weight, height, race/ethnicity, as well as questions about conditions that may exclude your child from participating. Examples of conditions that would exclude your child from participating include but are not limited to heart or breathing disease, bone and joint pain and poor physical health on the day of testing. If you and your child agree to participate in this research study, your child will:
· wear a device that measures activity level by sensing movement. The device is a small light weight box on a light belt that is worn at the waist. You or your child will wear it for 5 days. The amount of activity will be recorded.
· stand in normal relaxed posture while photographs/videos are taken to record movement and posture. Reflective markers will be placed with two-sided tape on the child at easily accessible boney structures, such as the shoulders, hips, knees, ankles, upper and lower back and head, to assess movement and posture.
· have body composition measured using skin fold calipers. At predetermined locations on the arm and shoulder blade, the skin and normally occurring fat under the skin will be gently held while a skin fold caliper is placed on the held skin. The device will measure the thickness of the skin and fat under the skin. This measurement will be recorded.
· Perform the functional movement screen. In this screen your child will perform activities that will assess balance, motion and strength. These will include such activities as stepping over a cord, squatting down, kneeling, and other movement tasks.
· perform a variety of balance tests, including:
Prone-bridge test: your child will be propped up above the ground by their toes and elbows and will stay in that position for as long as they can.
Prone-bridge test: your child will be propped up above the ground by their toes and elbows and will stay in that position for as long as they can.
Standing stork: your child will stand on one foot for as long as he or she can.
Side-bridge: your child will be propped up above the ground by their two feet and one elbow and will stay in that position as long as they can.
Test will be performed two or three times each.
· Total time commitment will be less than one hour
Risks/Discomforts
There are minimal risks for participation in this study. However, the strength tests require muscle contraction and movement. It is unlikely that any discomfort or soreness will result from participation; if you do feel discomfort or soreness, or feel that you cannot do the activity you stop participation.
Benefits
There are no direct benefits to the participant. However, it is hoped that through your participation researchers will learn more about posture, activity level, fitness, and muscle strength, and hopefully lead to better recommendations for lifestyle and health.
Confidentiality
All information and test results obtained will remain confidential and will only be reported as average data in the population with no individually identifying information. The research data will be kept in a secure location or on a password protected computer, and only the researcher will have access to the data. At the conclusion of the study, all identifying information will be removed and the data will be kept in the researcher’s locked cabinet or office.
Compensation
You or your child will receive about $5 or equivalent for you or your child’s participation at the end of testing. If the testing is not complete you or your child will not receive the reimbursement.
Participation
Participation in this research study is voluntary. You or your child has the right to withdraw at any time or refuse to participate entirely without jeopardy to his or her status, grades, or standing with the educational institution.
Questions about the Research
If you have questions regarding this study, you may contact Wayne Johnson, PhD, PT at 1-801-422-5490, , wayne_johnson@byu.eduUlrike Mitchell, PhD, PT at 1-801-422-3344, rike_mitchell@byu.edu;; Bill Myrer, PhD at 1-801-422-2690, bill_myrer@byu.edu or Uvacsek Martina, PhD at +36 1 487 9275, martina@mail.hupe.hu
Questions about your Rights as Research Participants
If you have questions regarding your rights as a research participant, you may contact or IRB Administrator, 1 (801) 422-1461, A-285 ASB Campus Drive, Brigham Young University, Provo, UT 84602, irb@byu.edu.
I have read, understood, and received a copy of the above consent and desire of my own free will to participate in this study.
Signature: Date:
(I am in the process of translating this form into Spanish)
Child’s Assent Form
We are studying questions about health, strength, and movement. We will ask you questions about you and have you do activities to see:
· how you stand,
· how you move,
· how much you move,
· how strong you are,
· how much bone, muscle and fat your body is made of
· how tall you are and how much you weigh
We will ask you to do the following:
· You will wear a belt with a light little box that measures how much you move for 5 days
· You will stand on a mark, while we take pictures or video clips of how you stand and then how you move as you bend forward; bend backward and to the sides. Reflective balls will be placed on your shoulders, hips, knees, ankles, back and head with tape.
· You will do simple exercises to see how strong you are.
· Some skin on your arms and the fat under the skin will be held and a plastic device will be placed on the skin to measure how thick the skin and fat are together.
· Your height and weight will be measured
When you are finished doing all of these things, we will give you ______________.
________________________________________________________
I understand that I do not have to do any part of this study. If I change my mind, I can quit the study at any time. Only the researchers will see my test results except if my parents want a copy.
Now I think I know about the study and what it means – Here is what I decided:
No, I do not want to be in the study Yes, I will be in the study
Your name (printing is OK) _____________________________________ Date _____________
I certify that this study and the procedures involved have been explained to_________________ in terms he/she could understand and that he/she freely assented to participate in this study.
Signature of Person Obtaining Consent ____________________________ Date _____________
Forma de Asentimiento para el Niño
Estamos estudiando preguntas acerca de la salud, fuerza y movimiento. Le haremos preguntas acerca de ti y hacerte participar en actividades para ver:
· Como te paras
· Como te mueves
· Cuanto te mueves
· Cuan fuerte eres
· De cuanto hueso, musculo y grasa tu cuerpo está hecho
· Cuan alto eres y cuanto pesas
Te preguntaremos lo siguiente:
· Usaras un cinturón con una cajita que medirá cuanto te mueves por 5 días
· Te pararas en una marca, mientras nosotros tomamos fotos de cómo te paras y luego de cómo te mueves mientras te doblas hacia adelante; hacia atrás y los costados. Unas pelotas reflexivas se pondrán en tus hombros, caderas, rodillas, tobillos, espalda y cabeza con cinta.
· Harás ejercicios simples para ver cuán fuerte eres.
· Una porción de piel en tus brazos y de grasa debajo de la piel será agarrada y un aparato de plástico será puesto sobre la piel para medir cuan grueso son la piel y grasa.
· Tu altura y peso será medido
Cuando hayas terminado de hacer todas estas cosas, te daremos ________________ ___________________________________________________________________.
Entiendo que no tengo que hacer ninguna parte de este estudio. Si cambio de opinión, puedo dejar este estudio en cualquier momento. Solo los investigadores verán mis resultados a menos que mis padres quieran una copia.
Ahora pienso que sé acera del estudio y lo que significa – Esto es lo que he decidido:
No, no quiero ser parte de este estudio Si, quiero ser parte de este estudio
Tu nombre (imprenta está bien) _____________________________________Fecha________________
Certifico que este estudio y los procedimientos han sido explicados a ____________________ en términos que el/ella pueden entender y que el/ella libremente participan en este estudio.
Firma de la Persona Obteniendo el Consentimiento _____________________Fecha________________
Appendix F – Questionnaires, Surveys, Instruments, Interview questions, etc.
Appendix H – All other supporting documents such as letters of support from other institutions or universities, grant applications, vitae, etc.
1. Deep Squat: This assessment involves standing with the feet about shoulder width apart (with both feet aligned in the sagittal plane). Holding a light-weight four-foot dowel overhead (with the hands about shoulder width apart) and the elbows extended, the individual descends slowly into a squat position until the buttocks are lower than the knees. The squat should be performed with the heels flat on the floor, the head and chest facing forward, and the dowel maximally pressed overhead. As many as three repetitions may be performed. A passing score of three is given for the squat when: the upper torso is parallel with the tibia or toward vertical; the femur of each leg is below horizontal; the feet remain flat on the floor in the sagittal plane; the knees are aligned over the feet; and the dowel remains in line with the feet. If the criteria for a score of three are not achieved, the individual is asked to perform the squat again with a 2” plank positioned under the heels (a score of two is given if the above criteria used for a score of three are reached using the heel lift, while a score of one is given if the person is not able to meet the above criteria). A score of zero is given if the individual experiences any pain during any portion of this test.
2. Hurdle Step: This assessment involves standing with the feet together (feet touching at both heels and toes), with the toes aligned and touching the base of the hurdle (the 2”x 6” plank). The physical hurdle consists of a piece of rubber tubing stretched across two support beams at the height of the individual’s tibial tuberosity. A dowel is positioned across the individual’s shoulders, below the back of the neck. The individual attempts to step over the hurdle with one foot and touch the heel to the floor while maintaining a tall spine (with minimal movement in the lumbar spine), and then returns the moving leg to the start position. During the assessment, the dowel resting on the shoulders should remain level and the hip, knee, and ankle of the moving leg should remain aligned in the sagittal plane. The hurdle should be performed slowly and under control. A total of three attempts bilaterally may be performed. A passing score of three is given when the hurdle step is performed as described above. A score of two is given when alignment is lost between the hip, knee, and ankle of the moving leg; movement is noted in the lumbar spine; or the dowel and hurdle do not remain parallel. A score of one is given if contact between the foot and hurdle occurs or there is a loss of balance. A score of zero is given if the individual experiences any pain during any portion of this test.
3. Inline Lunge: This assessment involves standing on top of the 2”x 6” plank in a split squat position with the feet separated by a distance (from the toe of one leg to the heel of the other leg) equal to the height from the floor to the top center of the individual’s tibial tuberosity (the same total height of the hurdle used in the previous assessment). The individual holds a dowel behind the back, touching the head, thoracic spine, and sacrum. The individual’s hand opposite the forward foot should be the hand holding the dowel at the cervical spine. The other hand holds the dowel at the lumbar spine. To perform this test the individual simply lowers the body until the rear knee touches the plank and then returns to the start position. During the downward and upward movements of the body, the dowel must remain vertical at all times. A total of three attempts involving each leg may be performed. A passing score of three is given when the dowel remains in contact with the head, thoracic spine, and sacrum at all times; the dowel remains vertical; no torso twisting movement is noted; the dowel and feet remain in the sagittal plane; and the knee touches the plank behind the heel of the front foot. A score of two is given when the dowel contacts are not maintained; the dowel does not remain vertical; twisting motion is noted in the torso; the dowel and feet do not remain in the sagittal plane; or the knee does not touch behind the heel of the front foot. A score of one is given if a loss of balance is noted at any time during the test. A score of zero is given if the individual experiences any pain during any portion of this test.
4. Shoulder Mobility: This assessment involves standing with feet together with each hand made into a fist (and each thumb tucked within the fist). The individual then simultaneously reaches one fist behind the neck and the other behind the back, assuming a maximally adducted, extended and internally rotated position with one shoulder, and a maximally abducted, flexed, and externally rotated position with the other shoulder. During the test, the hands should move in a smooth motion, and should remain fisted, with the measurement equal to the distance between the two closest points of the hands. A total of three attempts may be performed. A passing score of three is given when the fists are within one hand length. (Note: the individual’s hand length is measured before the test by finding the distance from the distal wrist crease to the tip of the longest digit). A score of two is given when the two closest points of the fists are within one-and-a-half hand lengths. A score of one is given when the the two closest points of the fists are not within one-and-a-half hand lengths. A score of zero is given if the individual experiences any pain during any portion of this test.
In addition, a shoulder clearing test (to assess possible shoulder impingement) is given at the end of this assessment by having the individual place a palm on the opposite shoulder and to lift the elbow as high as possible while maintaining the palm-to-shoulder contact. If any pain is experienced, a score of zero is given on the entire shoulder reach test.
5. Active Straight-Leg Raise: The individual lies supine with the arms at the sides, palms up, and the head flat on the floor. The 2”x 6” plank is positioned under the knees with both legs straight and feet neutral (with the soles of the feet perpendicular to the floor). The test administrator positions a dowel halfway between the anterior superior iliac spine (ASIS) and the joint line of the knee, and holds the dowel perpendicular to the floor. The individual is asked to lift the test limb as high as possible, while maintaining the original joint angle start position of the ankle and knee. Upon reaching end-range, the administrator checks the position of the upward limb relative to the non-moving limb. A total of three attempts involving each leg may be performed. A passing score of three is given when the leg moves to a point so the vertical line of the malleolus resides between the mid-thigh and the ASIS and the nonmoving leg remains in a neutral position (with the leg in contact with the plank). A score of two is given if the leg moves high enough so the vertical line of the malleolus resides between the mid-thigh and the joint line of the knee and the nonmoving leg remains in a neutral position. A score of one is given when the vertical line of the malleolus resides below the knee’s joint line while the non-moving leg remains a neutral position. A score of zero is given if the individual experiences any pain during any portion of this test.
6. Trunk Stability Push-up: The individual lies prone with the hands extended overhead. To prepare for the assessment, men should position their hands just greater than shoulder-width with their thumbs even with the top of their forehead, and women should position their hands just greater than shoulder-width with their thumbs even with their chin. With the knees fully extended, the ankles neutral, and the soles of the feet perpendicular to the floor, the individual performs one push-up with the body lifted as a unit with no sway in the spine during the test. A passing score of three is given when the individual performs the push-up as described. If the individual fails to earn a three, the hand position is adjusted and a score of two is given when the individual lifts his or her body as a unit with no lag in the spine (with men performing a push-up repetition with the thumbs aligned with the top of the chin and women with the thumbs aligned with the clavicle). A score of one is given when the individual is unable to lift his or her body as a unit with no lag in the spine (with men using the easier hand position with the thumbs aligned with the chin and women using the easier hand position with the thumbs aligned with the clavicle). A score of zero is given if the individual experiences any pain during any portion of this test.
In addition, a spinal extension press-up clearing test is given at the end of this test by having the individual get into the push-up start position and then pressing the shoulders upward by fully extending the arms, while keeping the hips, knees, and toes in contact with the floor. If any pain is experienced, a score of zero is given on the entire trunk stability test.
7. Rotary Stability: The individual gets into the quadruped position with the 2” x 6” plank between the hands and knees (shoulders and knees should be 90 degrees relative to the torso, with the ankles neutral and the feet perpendicular to the floor) and the plank positioned directly below and parallel with the spine. Before movement begins, the hands should be open, with the thumbs, knees, and feet all touching the plank. The individual should first fully flex one shoulder while fully extending the same-side hip and knee, and then touch this same-side elbow and knee together while remaining in line with the board. Spinal flexion is acceptable as the individual brings the knee and elbow together. This may be performed bilaterally for a maximum of three attempts if needed. A passing score of three is given when the individual performs a correct unilateral repetition as described above. If a score of three is not attained, have the person perform a diagonal pattern. In this case, a score of two is given when the individual touches the opposite elbow to knee directly above the plank. A score of one is given when the individual is unable to perform a correct diagonal repetition (and not touch opposite elbow to knee or experiences a loss of balance during the assessment). A score of zero is given if the individual experiences any pain during any portion of this test.
In addition, a spinal flexion clearing test is given at the end of this test by having the individual get into the quadruped position and then rock backward until the hips touch the heels of the feet and the chest moves to the thighs. The hands should remain in front of the body, reaching out as far as possible. If any pain is experienced, a score of zero is given on the entire rotary stability test.
