Outcomes of Group Dance and Movement Training in Ambulatory MS Patients

NCT05943145 | Completed

• 2 other identifiers: 23-1001863441-38-20
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

dance; movement

Outcome Measures

Primary Outcomes (2)

• 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.

  4 months

• 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.

  4 months

Secondary Outcomes (3)

• Neuro-QOL Positive Affect and Well-Being - Short Form

  4 months

• Neuro-QOL Lower Extremity Function (Mobility) - Short Form

  4 months

• Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form

  4 months

Study Arms (1)

Group Dance and Movement Training

EXPERIMENTAL

Group dance and movement sessions

Other: Group Dance and Movement Training

Interventions

Group Dance and Movement Training OTHER

Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety

Group Dance and Movement Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GroundWorks DanceTheater: lead

Study Sites (1)

Cleveland State University

Cleveland, Ohio, 44115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Francois Bethoux, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: July 13, 2023
• Study Start: April 24, 2023
• Primary Completion: July 14, 2023
• Study Completion: November 27, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)