Strength Training to Improve Gait in People With Multiple Sclerosis

Study Overview
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Brief Summary
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This study will pilot a strengthening intervention targeted to muscles found to be important to gait in people with multiple sclerosis (MS). Previous studies that have tried to strengthen leg and trunk muscles in people with MS have failed to improve walking ability consistently. The investigators think that is because strengthening exercises were not targeted to the correct muscle groups. For this study the investigators propose targeting muscle groups that they have found to be strong contributors to walking in a prior study. This is the first study to target these muscles, so the investigators propose doing a small trial to first evaluate the feasibility of the strength program and the outcomes. The investigators will measure strength and walking measures twice before and once after an 8-week strengthening intervention in a single group of 10 people with MS who are able to walk independently. The results of this study will help inform future, larger trials that could change the way strength training is conducted in people with MS.

Official Title
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Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Other: Strength exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with MS, Age 18-65, A confirmed diagnosis of MS, and Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds. Exclusion Criteria: Subjects are not ambulatory, Subjects rely on a wheelchair, Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics, Walk the T25FW in less than five seconds, Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS), Have pain or other conditions that limit ambulation or ability to test muscle strength, Cannot give consent, Cannot follow simple directions, Have had an exacerbation in the past month, Have had changes to their drug therapy in the last month, Have other neurologic diagnoses, or Are currently undergoing physical therapy for strength training.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength training<br>Strength exercises for ankle PF, hip abduction, and trunk muscles. Exercises will be done in three standard positions of supine, sidelying, prone, seated, and standing. Exercises during the initial 4 weeks will be completed 2x week with supervision of a physical therapist and 2x week at home, for a total of 4x week. For the final 4 weeks of the intervention will be completed 1x week with supervision and 3x week at home. | Other: Strength exercise<br>* Strengthening exercises performed with physical therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Muscle Strength | Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests | Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up) | 
| Change in Timed 25 Foot Walk (T25FW) | Gait speed over a 25 foot distance | Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-Minute Walk Test | Gait endurance | Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up) | 
| Change in Dynamic Gait Index | Balance during gait and other functional activities | Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up) | 
| Change in Multiple Sclerosis Walking Scale-12 | Self-report measure of limitations in walking related activities | Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up) | 
| Change in Patient Specific Functional Scale | Self reported measure of self-selected limitations in participation | Week 0 (Baseline 1); Week 10 (Follow-Up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, physical therapy