ClinicalTrials.gg
CompletedNCT02933515MY-OTUpdated Oct 14, 2016

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

A Phase 1 interventional study of yoga and occupational therapy in Stroke, sponsored by Colorado State University. Completed. Open to participants aged 59 Years and older. Per ClinicalTrials.gov, last updated 2016-10-14.

Sponsored by Colorado State University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
59 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

Browse trials for

Keywords

  • yoga
  • occupational therapy
  • stroke
03

In context

Stroke

7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 14 is below the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Colorado State University is the lead sponsor of 116 studies on the registry; 20 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
59 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • people with life expectancy \<9 months;
  • inability to attend sessions due to unresolved transportation issues;
  • inability or refusal to provide informed consent
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • Otheryoga 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

06

What researchers measure

Primary outcomes

  1. Change in balance using Berg Balance Scale

    14 items to assess balance

    Time frame: 8 weeks

Secondary outcomes

  1. Change in balance confidence using Activities Balance Confidence Scale

    assess balance self-efficacy or confidence to maintain balance while doing different actions

    Time frame: 8 weeks

  2. Change in falls management behaviors using the Falls Management Behavior Questionnaire

    assess the knowledge of how to manage and change behaviors associated with falls

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2014, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2016
First posted
Oct 14, 2016
Start
Jul 2014
Primary completionActual
Aug 2015
CompletionActual
Aug 2015
Last update
Oct 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02933515
Collaborators
American Occupational Therapy Foundation
Responsible party
Arlene Schmid (Associate Professor, Colorado State University) — Principal investigator
First posted
Oct 14, 2016
Start date
Jul 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Oct 14, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion