- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03578653
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2 (MY-OT for PD)
July 24, 2019 updated by: Colorado State University
The full program is focused on identifying and reducing risk factors surrounding falls.
Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk.
The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Fort Collins, Colorado, United States, 80521
- Colorado State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals with a diagnosis of Parkinson's disease OR their care partners
- Individuals who read and understand English
- Individuals who can stand with or without an assistive device
- People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
- People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
- score of at least 4/6 on the short mini mental status exam
Exclusion Criteria:
- less than 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Merging Yoga and Occupational Therapy for Parkinson disease
The group participates in three assessment periods: August, October, and December.
Then in October-December the group will receive group occupational therapy and recommended community adaptive yoga programming 2x/week for 8 weeks.
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The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk.
The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fall Risk Factor Management
Time Frame: Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
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Self-report 5 scales measuring the ability to manage fall risk factors
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Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laura Grimm, MS, Colorado State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
December 31, 2018
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
June 13, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 6, 2018
Study Record Updates
Last Update Posted (Actual)
July 25, 2019
Last Update Submitted That Met QC Criteria
July 24, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-7398H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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