Targeted ballet program for people with multiple sclerosis
| ISRCTN | ISRCTN67916624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67916624 |
| Protocol serial number | PP3418 |
| Sponsor | University of Illinois at Urbana-Champaign |
| Funder | National Multiple Sclerosis Society |
- Submission date
- 13/07/2017
- Registration date
- 21/07/2017
- Last edited
- 05/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Multiple sclerosis (MS) is a condition which affects the brain and/or spinal cord and causes problems with vision, movement, sensation and balance. Walking impairment is common in MS, particularly with advancing disability. Walking and mobility are among the most valued functions of people with MS. This shows the importance of finding approaches to restore walking in MS, particularly among people with advanced disease whose walking impairment affects their quality of life and independence. Researchers have noted that rehabilitation is the only way of improving function in MS, and exercise training seems to be an effective approach that has other positive side effects and benefits. There are two major gaps in the existing evidence of exercise and walking in MS. There is no documented evidence for improving agility or smooth coordination of movements in exercise interventions for those with MS. The focus on agility and smoothness of movement is critical for improving gait and movement. Such improvements lead to more walking and social engagement, whereas lack of coordination in gait and poor balance lead to an increased risk of falling and injury. A ballet program has been designed that should improve agility, balance and whole body movement coordination in people with MS who have walking impairment. The aim of this study is to assess the feasibility, safety and effectiveness of this ballet program for people with MS who have problems with mobility and coordination. This study will estimate the effect of the ballet program on balance, agility and smoothness of movement for the design of larger studies.
Who can participate?
Patients aged 18 and over with MS
What does the study involve?
Participants are trained twice a week for one hour in the dance class for a total of 16 weeks. Changes in balance, agility and smoothness of movement are assessed before and after the 16 weeks of classes.
What are the possible benefits and risks of participating?
This study may broaden the scope of treatment and rehabilitation in people with mild to severe MS in the near future at a fraction of the cost of traditional drug treatment. The rehabilitation of motor impairments through dance may improve disease management and the personal and social aspects of a patient’s life. Beyond the common physical and psychological benefits of exercise training, there are potential additional benefits for participants including improvements in neurological (nervous system) disability and walking mobility. There are risks of injury for people engaging in an exercise program after a prolonged period of inactivity. Such risks include strains, sprains, muscle soreness, joint pain and general fatigue, but serious physical injury is unlikely given the screening, physician approval, and oversight by trained exercise specialists and researchers, and periods of rest between interventions. Risks of injury and harm are reduced by including appropriate warm-up and cool-down exercises and promoting gradual increases in exercise over time. The exercise training is performed in an environment with air conditioning and multiple fans to control the temperature. The participants are allowed to drink water as needed through the exercises periods to avoid dehydration. Participants are reminded to stop exercising and inform the staff if they experience a negative reaction such as chest pain, shortness of breath, light headedness, or nausea. Participants are fully informed of the risks of starting an exercise program. Fear of falling, slips, trips and falls are possible during the mobility measurements. This risk will be minimized by allowing for the use of assistive devices (i.e., ankle-foot orthoses and canes) and steady surfaces during testing as well as having a gait belt around the participant’s waist and a research assistant within arms’ reach for stabilizing the participant in the event of a slip, trip or fall.
Where is the study run from?
University of Illinois at Urbana Champaign (USA)
When is the study starting and how long is it expected to run for?
May 2015 to December 2016
Who is funding the study?
National Multiple Sclerosis Society (USA)
Who is the main contact?
Prof. Citlali Lopez-Ortiz
lopezort@illinois.edu
Contact information
Public
906 S Goodwin Avenue
Urbana
61801
United States of America
 ORCID ID |
0000-0002-2969-3184 |
|---|---|
| Phone | +1 (0)217 300 1022 |
| lopezort@illinois.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center one-arm non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Targeted dance program for improved mobility in multiple sclerosis |
| Study objectives | The targeted ballet program will safely improve balance, functional ability, gait characteristics and mitigate ataxia in adults with multiple sclerosis. |
| Ethics approval(s) | Office of the Vice Chancellor for Research, Office for the Protection of Research Subjects, 01/05/2015, ref: 15749 |
| Health condition(s) or problem(s) studied | Multiple sclerosis |
| Intervention | The TBP lasted one hour per session and met twice a week over the course of 16 weeks. Participants were allowed up to two absences and given opportunities to make up classes. The instructor who designed the TBP had teaching certification from the Bolshoi Academy of Ballet and training in the pathophysiology of motor disorders. Exercises focused on improving balance and general mobility, and reducing ataxia of movement. The class protocol had a core structure that started with seated ballet technique (20 min), followed by exercises using the ballet barres (15 min), and then exercises across the floor (20 min), and then followed by a cool-down period (5 min). The neuroscience of dance laboratory was used as the setting for the TBP. The laboratory was equipped with professional-grade ballet floors, barres, sound systems, piano, and piano accompanists. Mirrors, known to enhance limb position sense, provided real-time visual feedback. Ballet barres and trained assistants provided physical support and safety to participants while increasing the accessibility and adaptability of rehabilitative exercises. When deemed necessary for the safety of participants, gait belts were also used. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Clinical outcome measures obtained before and after the 4-month intervention period: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 15/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 14 |
| Key inclusion criteria | 1. Confirmation of MS diagnosis 2. 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 3. Expanded Disability Status Scale (EDSS) scores of 2.5-6.5 based on an examination by a Neurostatus certified examiner for indicating walking impairment 4. Relapse free in the past 30 days 5. Approval for exercise training 6. Aged 40 to 65 (corrected 13/12/2017: Aged 18 and over) |
| Key exclusion criteria | 1. 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 2. Change in use of disease modifying therapy in the past 6 months 3. Recent initiation of Ampyra or other medications that influence walking and mobility within the last 30 days 4. Presence of orthopedic conditions |
| Date of first enrolment | 01/05/2015 |
| Date of final enrolment | 15/09/2016 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Urbana
61801
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The unidentified datasets generated during and/or analysed during the current study will be stored in a publically available repository at the University of Illinois at Urbana-Champaign. The website link is: https://doi.org/10.13012/B2IDB-6858418_V1. There are no known legal or ethical restrictions at this time. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/10/2018 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 01/04/2016 | 05/09/2023 | No | No |
Additional files
- ISRCTN67916624_01April2016.pdf
- Protocol file
Editorial Notes
05/09/2023: Uploaded protocol (not peer reviewed).
22/10/2018: Publication reference added.
24/01/2018: Intention to publish date updated.
13/12/2017: Inclusion criteria updated.
