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Clinical Trials/NCT03175133
NCT03175133
Completed
N/A

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

University of Colorado, Denver1 site in 1 country11 target enrollmentMay 23, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Colorado, Denver
Enrollment
11
Locations
1
Primary Endpoint
Change in Muscle Strength
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2017
End Date
November 8, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • People with MS,
  • 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,

Outcomes

Primary Outcomes

Change in Muscle Strength

Time Frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests

Change in Timed 25 Foot Walk (T25FW)

Time Frame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)

Gait speed over a 25 foot distance

Secondary Outcomes

  • Change in 6-Minute Walk Test(Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up))
  • Change in Multiple Sclerosis Walking Scale-12(Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up))
  • Change in Patient Specific Functional Scale(Week 0 (Baseline 1); Week 10 (Follow-Up))
  • Change in Dynamic Gait Index(Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up))

Study Sites (1)

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