Multiple sclerosis Nervous System Diseases Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical outcome measures obtained before and after the 4-month intervention period: 1. Balance, measured using the Balance Evaluation Systems Test (BESTest). This test consists of evaluations on six factors that may impair balance in patients with MS: biomechanics, stability limits, postural responses, anticipatory postural adjustments, sensory orientation, and dynamic balance during gait. 2. Smoothness of movement, measured using the International Cooperative Ataxia Rating Scale (ICARS) 3. Agility, measured using the Timed-Up-&-Go test (TUG) included in the BESTest Quantitative measures obtained before and after the 4-month intervention period: 1. Balance, quantified using the decay of the center of pressure (COP) trajectories when stepping onto a force platform (AccuSway AMTI, MA) forward, backward, and sideways as fast as possible and attempting to hold still while looking straight ahead. The participants’ height, weight, and limb length measures will be obtained for the calculation of the force plate platform. 2. Agility, quantified from the velocity in the COP trajectories 3. Smoothness of movement, obtained for walking by computing a standard smoothness index on velocity data of body landmarks such as wrists, elbows, shoulders, hips, knees, toes, ankles, and top of head in a 5 meter walk using a motion capture system (Qualisys, Sweden). This motion capture system requires the placement of markers that reflect light secured to body landmarks with standard self-adhesive wrapping tape. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United States of America