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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02933515
First Posted: October 14, 2016
Last Update Posted: October 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Occupational Therapy Foundation
Information provided by (Responsible Party):
Arlene Schmid, Colorado State University
  Purpose
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.

Condition Intervention Phase
Stroke Other: yoga and occupational therapy Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Merging Yoga and Group OT (MY-OT)

Resource links provided by NLM:


Further study details as provided by Arlene Schmid, Colorado State University:

Primary Outcome Measures:
  • Change in balance using Berg Balance Scale [ Time Frame: 8 weeks ]
    14 items to assess balance


Secondary Outcome Measures:
  • Change in balance confidence using Activities Balance Confidence Scale [ Time Frame: 8 weeks ]
    assess balance self-efficacy or confidence to maintain balance while doing different actions

  • Change in falls management behaviors using the Falls Management Behavior Questionnaire [ Time Frame: 8 weeks ]
    assess the knowledge of how to manage and change behaviors associated with falls


Enrollment: 14
Study Start Date: July 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   59 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Arlene Schmid, Associate Professor, Colorado State University
ClinicalTrials.gov Identifier: NCT02933515     History of Changes
Other Study ID Numbers: 12-3805H
First Submitted: January 14, 2016
First Posted: October 14, 2016
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Arlene Schmid, Colorado State University:
yoga
occupational therapy
stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases