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Outcomes of Group Dance and Movement Training in Ambulatory MS Patients

Primary Purpose

Multiple Sclerosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Dance and Movement Training
Sponsored by
GroundWorks DanceTheater
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring dance, movement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Dance and Movement Training

Arm Description

Group dance and movement sessions

Outcomes

Primary Outcome Measures

Timed Up and Go (TUG)
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.
9 Hole Peg Test (NHPT)
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.

Secondary Outcome Measures

Neuro-QOL Positive Affect and Well-Being - Short Form
This is a self-reported quality of life measure which has been validated in people with MS to assess positive affect and well-being.
Neuro-QOL Lower Extremity Function (Mobility) - Short Form
This is a self-reported quality of life measure which has been validated in people with MS to assess mobility.
Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form
This is a self-reported quality of life measure which has been validated in people with MS to assess fine motor and ADLs.

Full Information

First Posted
May 9, 2023
Last Updated
September 11, 2023
Sponsor
GroundWorks DanceTheater
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1. Study Identification

Unique Protocol Identification Number
NCT05943145
Brief Title
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
Official Title
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GroundWorks DanceTheater

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
dance, movement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Dance and Movement Training
Arm Type
Experimental
Arm Description
Group dance and movement sessions
Intervention Type
Other
Intervention Name(s)
Group Dance and Movement Training
Intervention Description
Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Description
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.
Time Frame
4 months
Title
9 Hole Peg Test (NHPT)
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Neuro-QOL Positive Affect and Well-Being - Short Form
Description
This is a self-reported quality of life measure which has been validated in people with MS to assess positive affect and well-being.
Time Frame
4 months
Title
Neuro-QOL Lower Extremity Function (Mobility) - Short Form
Description
This is a self-reported quality of life measure which has been validated in people with MS to assess mobility.
Time Frame
4 months
Title
Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form
Description
This is a self-reported quality of life measure which has been validated in people with MS to assess fine motor and ADLs.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Bethoux, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland State University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Outcomes of Group Dance and Movement Training in Ambulatory MS Patients

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