Strength Training to Improve Gait in People With Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Strength exercise

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. People with MS,
2. Age 18-65,
3. A confirmed diagnosis of MS, and
4. Are ambulatory for 100m without an assistive device (EDDS 0-5.5), and
5. Have a gait speed measured by time to walk the 25-foot walk test of at least five seconds.

Exclusion Criteria:

1. Subjects are not ambulatory,
2. Subjects rely on a wheelchair,
3. Subjects cannot ambulate 100m (EDDS 6 or greater) without use of assistive devices, braces, or orthotics,
4. Walk the T25FW in less than five seconds,
5. Have lower extremity spasticity of 2 or greater on the Modified Ashworth Scale (MAS),
6. Have pain or other conditions that limit ambulation or ability to test muscle strength,
7. Cannot give consent,
8. Cannot follow simple directions,
9. Have had an exacerbation in the past month,
10. Have had changes to their drug therapy in the last month,
11. Have other neurologic diagnoses, or
12. Are currently undergoing physical therapy for strength training.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Strength training; 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; Strengthening exercises performed with physical therapist.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Margaret Schenkman, PT, PhD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Helpful Links

• Link to publication

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2017
• Primary Completion (Actual): November 8, 2017
• Study Completion (Actual): November 8, 2017

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: rehabilitation; physical therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 16-2610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No