From: TCFD [
Sent: Sunday, January 17, 2016 12:28 PM
To: IRB
Subject: IRB Proposal Submission
The Center for Discovery IRB
Proposal Type (check all that apply): / CFD Proposal (Staff)
Project Title: / Physical Activity for Adults Aging with Multiple Disabilities
Contact Person at The Center For Discovery: / Alyce Sherwood
Email: /
Principal Investigator (Full Name): / Alyce Sherwoood
Affiliation: / The Center for Discovery
Address: / P.O. Box 840
Harris, New York 12742
United States of America
Email: /
Phone: / 845-707-8881
Human Protection Training Completion #: / 1948039
Is the Principal Investigator a Student: / No
Other Investigator 1 (Full Name): / Nicole Kinney
Affiliation Investigator 1: / The Center for Discovery
Address Investigator 1: / same as above
Email Investigator 1: /
Phone:
Human Protection Training Completion #:
Other Investigator 2 (Full Name): / Jim Cashen
Affiliation Investigator 2: / The Center for Discovery
Address Investigator 2: / same as above
Email Investigator 2: /
Phone:
Human Protection Training Completion #:
Other Investigator 3 (Full Name):
Affiliation Investigator 3:
Address Investigator 3:
Email Investigator 3:
Phone:
Human Protection Training Completion #:
State the research questions(s) to be addressed in this study: / What are the outcomes of a consistent exercise program for adults aging with multiple disabilities?
Briefly state how this study advances knowledge; reference relevant specific literature.: / This study will examine the application of the National Center on Physical Activity and Disability (MyNCPAD) program with 21 adults aging with multiple disabilities. This is a replication of a study completed at the Center for Discovery in 2011. Present studies in the literature continue to the impact of exercise on individuals who are aging or who have multiple disabilities. This study will advance knowledge with a population that is rapidly growing in number. Application to other aging populations will also be reviewed.
Briefly state why this study should be conducted at The Center for Discovery.: / The Center for Discovery provides residential living for individuals aging with multiple disabilities ranging in age from 21 to 81. Energy regulation is a key component of the Center's HealthE6 model. This component of the program includes exercise, sleep and daily rhythms. This programmatic construct will facilitate the implementation of this study.
Specify age range, gender and approximate number of participants; describe any inclusion or exclusion criteria that may apply in the identification of participants.: / The study will include 21 participants- 12 females and 9 males. Age range is 21 to 81.
Inclusion criteria: Individuals aging with multiple disabilities ranging in age from 21 to 81. May be male or female, ambulatory or non- ambulatory. Diagnosis may include but is not limited to cerebral palsy, seizure disorder, osteoporosis, GERD. Must demonstrate cognitive ability to understand presented information via visual, written or verbal input.
Exclusion criteria: No one under 21 with medical restrictions as indicated by physician.
Describe the method of recruitment for participation, if any.: / Male and female individuals residing at the Center for Discovery, who meet the criteria, will be invited to participate in the study to benefit from healthy lifestyle changes. No specific inducement.
Describe the method of accessing existing records/Data at The Center for Discovery, if any.: / Residence specific program books will be reviewed. Medical information will be accessed through e-clinical.
Check one or more of the designs applicable to this study:: / Single group study, Analysis of records/existing data, Data collection on two or more occasions (i.e., repeated measures)
Check one or more of the methods applicable to this study:: / Non-invasive procedure, Behavioral observation, Interview, Direct assessment/testingg, Video-recording
What method(s) will be used to analyze data:: / Descriptive, Quantitative
Describe the qualitative method(s) to be used:
Describe the quantitative method(s) to be used: / Analysis of pre and post assessment data
Will research assistants be used for data collection or analysis?: / No
If yes, please describe:
Are any potential study outcomes expected to contribute to generalized knowledge: / Yes
Describe how the study will contribute to the generalized knowledge: / Study results will contribute to the field of knowledge regarding the impact of exercise on those aging with multiple disabilities.
Are any potential study outcomes expected to directly benefit participants?: / Yes
Identify potential for benefits, if any, to participants in the study: / Positive physical and psychological benefits relative to the impact of exercise.
Are any potential study outcomes expected to benefit the Center for Discovery: / Yes
Do you or any of your immediate family members stand to gain financially or materially based on the outcome of this study?: / No
Please describe:
Are any potential study outcomes expected to have intellectual property or commercial implications?: / No
Is/are there any incentive or compensation for participation in the study: / No
If yes, please describe::
Is there deception involved in the study?: / No
If yes, please describe::
Check applicable categories below, if there are any known or potential risks associated with study procedures and/or data collection describe what will be done to minimize the risks:: / Physical
What steps will be taken to minimize Physical Risk?: / Consent from physician prior to undertaking new exercise program.
Lesson is provided with exercise recommendations.
Physical injury is always a risk when performing exercise. We will provide demonstration, modeling and physical assistance as needed for each exercise.
Observation of individuals participating in the program.
Availability of team members by phone and email for assistance and advice.
What steps will be taken to minimize Psychological Risk?:
What steps will be taken to minimize Social Risk?:
What steps will be taken to minimize Legal Risk?:
What steps will be taken to minimize Economic Risk?:
Describe how consent will be obtained from participants or their legally authorized representative: (attach file in final section): / Participants must sign release and agree to initial meeting with team to go over the program. Participants will also complete pre and post evaluation.
Describe how assent will be obtained if relevant::
Describe applicable procedures to insure confidentiality of data (e.g., coding, de-identification, pseudonyms…): / Initials will be utilized to maintain confidentiality of data.
Describe applicable procedures to insure security of data (e.g., locked storage, encryption of data, password protection…): / Password protection will be utilized to insure security of data.
Consent Form:
External IRB approval letter:
Recruitment Letter/Form:
Measures/Questionnaires:
Grant Application:
Student Thesis/Dissertation Proposal:
Other Study Protocol:
Number of additional documents to upload:: / 0
Additional upload - 1:
Additional upload - 2:
Additional upload - 3:
Additional upload - 4:
Professional Association: / Speech-Language Pathologist
Principal Investigator: / Alyce Sherwood
Today's Date: / 01/18/2016
Hidden: / 24.39.104.92