- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05943145
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
November 27, 2023 updated by: GroundWorks DanceTheater
GroundWorks DanceTheater and Cleveland Clinic are partnering to create and offer an initial study of a dance movement-based community program for people with Multiple Sclerosis (MS).
The program will address major needs in the MS community including social-emotional well-being, body awareness, and motor function.
GroundWorks artists will use a variety of widely accepted movement-based practices with the goal of improving upper and lower body function and overall well-being.
By partnering, GroundWorks and Cleveland Clinic hope to encourage more study of the benefits of dance movement-based programming in individuals affected by MS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
GroundWorks DanceTheater and Cleveland Clinic are partnering to design and implement a pilot study of a dance movement-based community program for people with Multiple Sclerosis (MS).
The program is aimed at addressing major needs in the MS community including social-emotional well-being, body awareness, and motor function.
GroundWorks artists will use a variety of movement-based practices including personalized tasks and imagery, mirroring, and inscription, with the goal of improving upper and lower extremity function, and well-being.
Cleveland Clinic will assist GroundWorks in the selection, monitoring, and testing of the participants.
Cleveland Clinic will also take the lead with data management and analysis.
By partnering, GroundWorks and Cleveland Clinic hope to create a promising program that will lead to further exploring the impact of dance movement-based programming in individuals affected by MS.
Study Type
Interventional
Enrollment (Actual)
6
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
-
-
Ohio
-
Cleveland, Ohio, United States, 44115
- Cleveland State University
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 18 to 65 inclusive
- diagnosis of MS (relapsing or progressive form) based on the revised MacDonald Criteria established by a neurologist
- self-reported upper and lower extremity dysfunction
- ability to walk safely without an assistive device (e.g. cane, walker) indoors and outdoors
Exclusion Criteria:
- comorbidity (e.g. cardiac, respiratory, musculoskeletal) representing a contra-indication to the dance movement program
- exacerbation of MS within the past 60 days
- severe cognitive impairment
- clinically significant concern regarding the participant's ability to safely perform study procedures
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Dance and Movement Training
Group dance and movement sessions
|
Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go (TUG)
Time Frame: 4 months
|
This is a test of functional mobility, commonly used for people with MS.
The test measures the time it takes for a person to stand up from a chair, walk 10 feet, turn around, walk back to the chair and sit down.
|
4 months
|
|
9 Hole Peg Test (NHPT)
Time Frame: 4 months
|
This is a widely used test of upper extremity function in people with MS.
The test measures the time it takes for a person to pick up 9 pegs individually and place each one in one of 9 holes on a board and then take each one out, one at a time, and place the pegs back in the container.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuro-QOL Positive Affect and Well-Being - Short Form
Time Frame: 4 months
|
This is a self-reported quality of life measure which has been validated in people with MS to assess positive affect and well-being.
|
4 months
|
|
Neuro-QOL Lower Extremity Function (Mobility) - Short Form
Time Frame: 4 months
|
This is a self-reported quality of life measure which has been validated in people with MS to assess mobility.
|
4 months
|
|
Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form
Time Frame: 4 months
|
This is a self-reported quality of life measure which has been validated in people with MS to assess fine motor and ADLs.
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Francois Bethoux, PhD, The Cleveland Clinic
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)
April 24, 2023
Primary Completion (Actual)
July 14, 2023
Study Completion (Actual)
November 27, 2023
Study Registration Dates
First Submitted
May 9, 2023
First Submitted That Met QC Criteria
July 9, 2023
First Posted (Actual)
July 13, 2023
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-100
- 1863441-38-20 (Other Grant/Funding Number: National Endowment for the Arts)
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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