Clinical trial NCT05943145: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: dance
movement
Lead sponsor: GroundWorks DanceTheater
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: 4 months
measure: 9 Hole Peg Test (NHPT)
timeFrame: 4 months
Secondary outcomes:
measure: Neuro-QOL Positive Affect and Well-Being - Short Form
timeFrame: 4 months
measure: Neuro-QOL Lower Extremity Function (Mobility) - Short Form
timeFrame: 4 months
measure: Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form
timeFrame: 4 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland State University
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Francois Bethoux, PhD
role: PRINCIPAL_INVESTIGATOR
References: