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

Merging Yoga and Group OT (MY-OT)

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: yoga and occupational therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 59 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Yoga and occupational therapy; twice a week for 8 weeks. one hour of group occupational therapy for fall risk factor management and one hour of yoga for balance	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in balance using Berg Balance Scale	14 items to assess balance	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in balance confidence using Activities Balance Confidence Scale	assess balance self-efficacy or confidence to maintain balance while doing different actions	8 weeks
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

Collaborators and Investigators

• Sponsor: Colorado State University
• Collaborators: American Occupational Therapy Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (ESTIMATE): October 14, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: stroke; yoga; occupational therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 12-3805H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO