Back to resultsMerging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke (MY-OT)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
yoga and occupational therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring yoga, occupational therapy, stroke
Eligibility Criteria
Inclusion Criteria:
- stroke >6 months prior
- 59 years or older
- prior fall or Fear of Falling (FoF)
- completed all stroke rehabilitation
- able to stand with or without an assistive device
- impaired balance with a score of <46 on the Berg Balance Scale
- able to speak English
- score >4 out of 6 on the short Mini Mental Status Exam (Callahan, Unverzagt et al., 2002)
- able and willing to attend twice weekly sessions for 8 weeks.
Exclusion Criteria:
- people with life expectancy <9 months;
- inability to attend sessions due to unresolved transportation issues;
- inability or refusal to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Yoga and occupational therapy
Arm Description
twice a week for 8 weeks. one hour of group occupational therapy for fall risk factor management and one hour of yoga for balance
Outcomes
Primary Outcome Measures
Change in balance using Berg Balance Scale
14 items to assess balance
Secondary Outcome Measures
Change in balance confidence using Activities Balance Confidence Scale
assess balance self-efficacy or confidence to maintain balance while doing different actions
Change in falls management behaviors using the Falls Management Behavior Questionnaire
assess the knowledge of how to manage and change behaviors associated with falls
Full Information
NCT ID
NCT02933515
First Posted
January 14, 2016
Last Updated
October 12, 2016
Sponsor
Colorado State University
Collaborators
American Occupational Therapy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02933515
Brief Title
Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke
Acronym
MY-OT
Official Title
Merging Yoga and Group OT (MY-OT)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Colorado State University
Collaborators
American Occupational Therapy Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The long-term goal of this project is to advance best practices in occupational therapy (OT) to manage fall risk factors and reduce fall rates in older adults with stroke. To address this long-term goal, this team previously developed and pilot-tested a therapeutic yoga intervention to improve balance, balance self-efficacy, and fear of falling and a group OT intervention to improve the management of fall risk factors and fear of falling. The success of both prior studies supports Merging Yoga and group OT to improve balance, balance self-efficacy, and fall risk factor management. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.
Detailed Description
8 week intervention of yoga plus occupational therapy. The objectives of this feasibility study are to 1) further develop, standardize, and manualize the MY-OT intervention and 2) assess change in balance, balance self-efficacy, and fall risk factor management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
yoga, occupational therapy, stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga and occupational therapy
Arm Type
Experimental
Arm Description
twice a week for 8 weeks. one hour of group occupational therapy for fall risk factor management and one hour of yoga for balance
Intervention Type
Other
Intervention Name(s)
yoga and occupational therapy
Intervention Description
group OT addressed fall risk factors, such as risk factors inside and outside and how to best manage them. yoga was delivered in sitting, standing, and floor postures
Primary Outcome Measure Information:
Title
Change in balance using Berg Balance Scale
Description
14 items to assess balance
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in balance confidence using Activities Balance Confidence Scale
Description
assess balance self-efficacy or confidence to maintain balance while doing different actions
Time Frame
8 weeks
Title
Change in falls management behaviors using the Falls Management Behavior Questionnaire
Description
assess the knowledge of how to manage and change behaviors associated with falls
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stroke >6 months prior
59 years or older
prior fall or Fear of Falling (FoF)
completed all stroke rehabilitation
able to stand with or without an assistive device
impaired balance with a score of <46 on the Berg Balance Scale
able to speak English
score >4 out of 6 on the short Mini Mental Status Exam (Callahan, Unverzagt et al., 2002)
able and willing to attend twice weekly sessions for 8 weeks.
Exclusion Criteria:
people with life expectancy <9 months;
inability to attend sessions due to unresolved transportation issues;
inability or refusal to provide informed consent
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke
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