Outcomes of Group Dance and Movement Training in Ambulatory MS Patients

• Sponsor: GroundWorks DanceTheater (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05943145
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 3.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: Group Dance and Movement Training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single groupUncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
• Actual Study Start Date: Apr 24, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Dance and Movement Training Group dance and movement sessions	Other: Group Dance and Movement Training; Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety

Outcome Measures

Primary Outcome Measures

1. Timed Up and Go (TUG) [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.

2. 9 Hole Peg Test (NHPT) [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.

Secondary Outcome Measures

1. Neuro-QOL Positive Affect and Well-Being - Short Form [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.

2. Neuro-QOL Lower Extremity Function (Mobility) - Short Form [4 months]

   This is a self-reported quality of life measure which has been validated in people with MS to assess mobility.

3. Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland State University	Cleveland	Ohio	United States	44115

Sponsors and Collaborators

• GroundWorks DanceTheater

Investigators

• Principal Investigator: Francois Bethoux, PhD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GroundWorks DanceTheater
• ClinicalTrials.gov Identifier: NCT05943145
• Other Study ID Numbers: 23-100; 1863441-38-20
• First Posted: Jul 13, 2023
• Last Update Posted: Jul 13, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GroundWorks DanceTheater: dance; movement
• Additional relevant MeSH terms: Multiple Sclerosis

Study Results

No Results Posted as of Jul 13, 2023