Parkinson DiseaseMY-OT for PDNCT03578653
Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
A study testing Merging Yoga and Occupational Therapy for Parkinson disease in people with Parkinson Disease, run by Colorado State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Merging Yoga and Occupational Therapy for Parkinson disease
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Mar 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- less than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Colorado State University
Fort Collins, Colorado, 80521
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Merging Yoga and Occupational Therapy for Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Merging Yoga and Occupational Therapy for Parkinson diseaseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Merging Yoga and Occupational Therapy for Parkinson disease | Experimental | 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. Receives: Behavioral: Merging Yoga and Occupational Therapy for Parkinson disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fall Risk Factor Management
Self-report 5 scales measuring the ability to manage fall risk factors
Measured: Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Grimm, MS, Principal investigator, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578653
- Sponsor's protocol ID
- 17-7398H
- Acronym
- MY-OT for PD
- Status last verified
- Feb 2019
- First submitted
- 13 Jun 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merging Yoga and Occupational Therapy for Parkinson Disease: Phase 2
- ClinicalTrials.gov ID
- NCT03578653
- Acronym / sponsor ID
- MY-OT for PD / 17-7398H
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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 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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Merging Yoga and Occupational Therapy for Parkinson disease | Experimental | Behavioral: Merging Yoga and Occupational Therapy for Parkinson diseaseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- less than 18 years of age
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 |
|---|---|---|
| Merging Yoga and Occupational Therapy for Parkinson diseaseThe 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. | Behavioural | Merging Yoga and Occupational Therapy for Parkinson disease |
Primary outcome
Change in Fall Risk Factor Management
Time frame: Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)
Self-report 5 scales measuring the ability to manage fall risk factors
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 25 Jul 2019.
- 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.
Laura Grimm, MS principal investigator
Colorado State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Merging Yoga and Occupational Therapy for Parkinson disease in people with Parkinson Disease, run by Colorado State University at 1 site in United States.
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 6 inclusion and 1 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Fall Risk Factor Management (time frame: Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)). 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 25 Jul 2019.