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Completed

NCT Number: NCT02933515

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

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.

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Key information

Age range

59 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in balance using Berg Balance Scale

    Time frame: 8 weeks

    14 items to assess balance

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Collaborators

  • American Occupational Therapy Foundation

Registry information

Official study title

Merging Yoga and Group OT (MY-OT)

Acronym: MY-OT

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 14, 2016
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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