Recruiting

Ballet Program

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT04073940

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Targeted Ballet Program

Study Details

Brief summary:

Multiple Sclerosis (MS) is an autoimmune disease of the central nervous system (CNS) affecting roughly 900,000 people in the United States that frequently results in impaired mobility. The majority of people with MS express that impaired mobility the most difficult aspect of living with the disease. Ataxia is one aspect of impaired mobility experienced by approximately 80% of persons with MS. Despite $9 billion in drug costs to patients with MS in the U.S., in 2012 alone, standard pharmacological treatment for MS is ineffective in restoring mobility and decreasing ataxia. The PI designed a targeted ballet program requiring motor learning of complex movements that mitigated ataxia and improved balance in patients with MS in a pilot study. The improvements obtained were approximately five times larger than those reported by other physical rehabilitation interventions. However, understanding these changes requires determining whether there are underlying changes in the brain after participation in the targeted ballet program.

This project involves persons with mild-to-moderate MS that present ataxia in their movement. We will compare the brain connectivity of participants in the targeted ballet program before and after the 16-week, twice per week, hourly participation intervention. Brain images will be obtained with magnetic resonance imaging while each participant rests with the eyes open. As a secondary outcome, measures of movement quality, ataxia, and balance will be taken to better understand the effects of the targeted ballet program on motor function, wellness, and the brains of persons with mild to moderate MS. Test on movement will include a 10 meter walk with motion tracking, a balance test using a force plate, and clinical tests of ataxia, balance, and walking speed. We will also assess changes in wellness with standard questionnaires.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study ID

NCT04073940

Start date

Aug 29, 2019

Status verified date

Dec, 2019

Completion date

Jan 15, 2021

Anticipated

Primary completion date

Jan 15, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age between 18-64
  • Informed consent obtained
  • Confirmation of relapsing remitting MS (RRMS) diagnosis by the participant's neurologist
  • Presence of ataxia determined by the International Cooperative Ataxia Rating Scale (ICARS) recommended by the NIH and the Ataxia Neuropharmacology Committee of the World Federation of Neurology with a score greater or equal to 7
  • Expanded Disability Status Scale (EDSS) scores of 1.0-6.5 based on an examination by a Neurostatus certified examiner for indicating walking impairment
  • Relapse free in the previous 30 days
  • Approval for exercise training.

Exclusion Criteria:

  • Presence of severe cognitive impairment based on an oral Symbol Digit Modalities Test (SDMT) score of less than 23, or the Montreal Cognitive Assessment (MoCA) Test less than 22
  • Inability to understand experimental instructions presented in English
  • Pregnancy
  • Education level less than 8th grade - due to concerns about understanding the study and consent form
  • Change in use of disease modifying therapy in the previous 6 months,
  • Initiation of Ampyra or other medications that influence walking and mobility within the previous 30 days,
  • History of brain injury or central nervous system disease other than multiple sclerosis - this will be determined from gross anatomical abnormalities in the images or from medical history on Biomedical Imaging Center (BIC) screening form,
  • Presence of orthopedic conditions,
  • The presence of any skin conditions preventing the safe usage of motion tracking marker adhesives
  • The presence of conditions which would contra-indicate MRI: prior surgeries and/or implant of pacemakers, pacemaker wires, artificial heart valve, brain aneurysm surgery, middle ear implant, non-removable hearing aid or jewelry, braces or extensive dental work, cataract surgery or lens implant, implanted mechanical or electrical device, artificial limb or joint; foreign metallic objects in the body such as bullets, BB's, shrapnel, or metalwork fragments; pregnancy, claustrophobia, uncontrollable shaking, or inability to lie still for 2 hours.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Targeted Ballet Program

A 16-week (32 sessions of 1 hour each) ballet-based intervention targeted to improve motor function in persons with multiple sclerosis.

Interventions

Targeted Ballet Program

All classes will be offered in a set schedule convenient for all participants. Classes will be taught by the PI, who has extensive dance training expertise. The targeted ballet program consists of an initial period of dance movements while sitting in chairs (20min), followed by exercises holding onto the ballet barres mounted to the walls in the Neuroscience of Dance on Health and Disability Laboratory (20min), followed by locomotive dance movements (20min). The dance moves are based on the Ballet I Syllabus of the Royal Academy of Dancing and the Cecchetti Council of America, designed for eight-year-old students with no necessary previous training in ballet.

Primary outcome measure

  • Structural Connectivity [ Time Frame: Before and after the 16-week intervention period ]
  • Resting-State Functional Connectivity [ Time Frame: Before and after the 16-week intervention period ]

Central Contacts and Locations

Central contacts

Citlali Lopez-Ortiz, PhD, MA

217-300-1022lopezort@illinois.edu

Locations

University of Illinois at Urbana-Champaign

Recruiting

Champaign, Illinois, United States, 61820

Contacts

Citlali Lopez-Ortiz, PhD, MA

217-300-1022lopezort@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Jan 3, 2020

Last verified

Dec, 2019

Keywords

  • multiple sclerosis
  • ataxia
  • magnetic resonance imaging
  • structural connectivity
  • resting state functional connectivity
  • dance
  • wellness
  • balance
  • mobility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2020-01-03.