Multiple SclerosisNCT05943145
Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
A study testing Group Dance and Movement Training in people with Multiple Sclerosis, run by GroundWorks DanceTheater at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Group Dance and Movement Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Group Dance and Movement Training
- Keywords
- dance, movement
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Dance and Movement TrainingOther
Dance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety
| Study group | Role | What they receive |
|---|---|---|
| Group Dance and Movement Training | Experimental | Group dance and movement sessions Receives: Other: Group Dance and Movement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months
Secondary outcomes (3)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start24 Apr 2023
- Primary completion14 Jul 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- GroundWorks DanceTheater
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Bethoux, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943145
- Sponsor's protocol ID
- 23-100
- Other IDs
- 1863441-38-20
- Status last verified
- Nov 2023
- First submitted
- 9 May 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Group Dance and Movement Training in Ambulatory MS Patients
- ClinicalTrials.gov ID
- NCT05943145
- Acronym / sponsor ID
- 23-100
- Conditions
- Multiple Sclerosis
- Keywords
- dance, movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- GroundWorks DanceTheaterUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 14 Jul 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled pre-post intervention study. All participants will complete 14 1-hour dance intervention sessions together as a single group
| Arm | Type | Receives |
|---|---|---|
| Group Dance and Movement Training | Experimental | Other: Group Dance and Movement TrainingGroup dance and movement sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Dance and Movement TrainingDance movement-based sessions including personalized tasks and imagery, mirroring, and inscription, plus warm-up and cool down practices to ensure physical safety | Other | Group Dance and Movement Training |
Primary outcome
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.
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.
3 secondary outcomes
Neuro-QOL Positive Affect and Well-Being - Short Form
Time frame: 4 months
Neuro-QOL Lower Extremity Function (Mobility) - Short Form
Time frame: 4 months
Neuro-QOL Upper Extremity Function (Fine Motor, ADL) - Short Form
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Bethoux, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Dance and Movement Training in people with Multiple Sclerosis, run by GroundWorks DanceTheater at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.