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

NCT02933515 | Completed Phase 1

• 1 other identifier: 12-3805H
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

yoga; occupational therapy; stroke

Outcome Measures

Primary Outcomes (1)

• Change in balance using Berg Balance Scale

  14 items to assess balance

  8 weeks

Secondary Outcomes (2)

• Change in balance confidence using Activities Balance Confidence Scale

  8 weeks

• Change in falls management behaviors using the Falls Management Behavior Questionnaire

  8 weeks

Study Arms (1)

Yoga and occupational therapy

EXPERIMENTAL

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

Interventions

yoga and occupational therapy OTHER

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

Yoga and occupational therapy

Eligibility Criteria

• Age: 59 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• stroke \>6 months prior
• 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.

You may not qualify if:

• people with life expectancy \<9 months;
• inability to attend sessions due to unresolved transportation issues;
• inability or refusal to provide informed consent

Sponsors & Collaborators

• Colorado State University: lead
• American Occupational Therapy Foundation: collaborator

MeSH Terms

Conditions

Stroke

Interventions

Yoga; Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: October 14, 2016
• Study Start: July 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 14, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share