Strength Training to Improve Gait in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strength exercise
Sponsored by

About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring rehabilitation, physical therapy
Eligibility Criteria
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.
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Strength training
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Muscle Strength
Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests
Change in Timed 25 Foot Walk (T25FW)
Gait speed over a 25 foot distance
Secondary Outcome Measures
Change in 6-Minute Walk Test
Gait endurance
Change in Dynamic Gait Index
Balance during gait and other functional activities
Change in Multiple Sclerosis Walking Scale-12
Self-report measure of limitations in walking related activities
Change in Patient Specific Functional Scale
Self reported measure of self-selected limitations in participation
Full Information
NCT ID
NCT03175133
First Posted
May 23, 2017
Last Updated
April 11, 2018
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03175133
Brief Title
Strength Training to Improve Gait in People With Multiple Sclerosis
Official Title
Targeted Strength Training to Improve Gait in People With Multiple Sclerosis: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2017 (Actual)
Primary Completion Date
November 8, 2017 (Actual)
Study Completion Date
November 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
rehabilitation, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strength training
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Strength exercise
Intervention Description
Strengthening exercises performed with physical therapist.
Primary Outcome Measure Information:
Title
Change in Muscle Strength
Description
Muscle strength measured by hand-held dynamometry (HHD) and clinical strength tests
Time Frame
Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Title
Change in Timed 25 Foot Walk (T25FW)
Description
Gait speed over a 25 foot distance
Time Frame
Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Secondary Outcome Measure Information:
Title
Change in 6-Minute Walk Test
Description
Gait endurance
Time Frame
Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Title
Change in Dynamic Gait Index
Description
Balance during gait and other functional activities
Time Frame
Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Title
Change in Multiple Sclerosis Walking Scale-12
Description
Self-report measure of limitations in walking related activities
Time Frame
Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Title
Change in Patient Specific Functional Scale
Description
Self reported measure of self-selected limitations in participation
Time Frame
Week 0 (Baseline 1); Week 10 (Follow-Up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Schenkman, PT, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29070966
Citation
Manago MM, Hebert JR, Schenkman M. Psychometric Properties of a Clinical Strength Assessment Protocol in People with Multiple Sclerosis. Int J MS Care. 2017 Sep-Oct;19(5):253-262. doi: 10.7224/1537-2073.2016-078.
Results Reference
background
Links:
URL
http://www.ijmsc.org/doi/abs/10.7224/1537-2073.2016-078?code=cmsc-site
Description
Link to publication
Learn more about this trial
Strength Training to Improve Gait in People With Multiple Sclerosis
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