Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke

Stroke Clinical Trial

— MY-OT  

Official title:

Merging Yoga and Group OT (MY-OT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933515
• Other study ID #: 12-3805H
• Status: Completed
• Phase: Phase 1
• First received: January 14, 2016
• Last updated: October 12, 2016
• Start date: July 2014
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 59 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• yoga and occupational therapy
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Colorado State University	American Occupational Therapy Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in balance using Berg Balance Scale	14 items to assess balance	8 weeks	No
Secondary	Change in balance confidence using Activities Balance Confidence Scale	assess balance self-efficacy or confidence to maintain balance while doing different actions	8 weeks	No
Secondary	Change in falls management behaviors using the Falls Management Behavior Questionnaire	assess the knowledge of how to manage and change behaviors associated with falls	8 weeks	No