StrokePhase 1MY-OTNCT02933515
Merging Yoga and Group OT (MY-OT) to Improve Balance and Decrease Fall Risk After Stroke
A Phase 1 study testing yoga and occupational therapy in people with Stroke, run by Colorado State University.
Trial 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… Read more about this study
- Who is it for?
- Ages 59 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- yoga and occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 59 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- people with life expectancy <9 months;
- inability to attend sessions due to unresolved transportation issues;
- inability or refusal to provide informed consent
About this study
Official title: 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.
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.
- Conditions
- Stroke
- Being tested
- yoga and occupational therapy
- Keywords
- yoga, occupational therapy, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yoga and occupational therapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: yoga and occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in balance using Berg Balance Scale
14 items to assess balance
Measured: 8 weeks
Secondary outcomes (2)
Change in balance confidence using Activities Balance Confidence Scale
assess balance self-efficacy or confidence to maintain balance while doing different actions
Measured: 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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startJul 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Responsible party
- Principal investigator, Arlene Schmid, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933515
- Sponsor's protocol ID
- 12-3805H
- Acronym
- MY-OT
- Status last verified
- Oct 2016
- First submitted
- 14 Jan 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merging Yoga and Group OT (MY-OT)
- ClinicalTrials.gov ID
- NCT02933515
- Acronym / sponsor ID
- MY-OT / 12-3805H
- Conditions
- Stroke
- Keywords
- yoga, occupational therapy, stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- American Occupational Therapy Foundation
- Study start
- Jul 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yoga and occupational therapy | Experimental | Other: yoga and occupational therapytwice a week for 8 weeks. one hour of group occupational therapy for fall risk factor management and one hour of yoga for balance |
Who may qualify
- Ages
- 59 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- people with life expectancy <9 months;
- inability to attend sessions due to unresolved transportation issues;
- inability or refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yoga and occupational therapygroup 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 | Other | Yoga and occupational therapy |
Primary outcome
Change in balance using Berg Balance Scale
Time frame: 8 weeks
14 items to assess balance
2 secondary outcomes
Change in balance confidence using Activities Balance Confidence Scale
Time frame: 8 weeks
Change in falls management behaviors using the Falls Management Behavior Questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing yoga and occupational therapy in people with Stroke, run by Colorado State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in balance using Berg Balance Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.