Strength Training to Improve Gait in People With Multiple Sclerosis

NCT03175133 | Completed

• 1 other identifier: 16-2610
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

rehabilitation; physical therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in 6-Minute Walk Test

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

• Change in Dynamic Gait Index

  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)

Study Arms (1)

Strength training

EXPERIMENTAL

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

Interventions

Strength exercise OTHER

Strengthening exercises performed with physical therapist.

Strength training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 29070966 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Margaret Schenkman, PT, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 5, 2017
• Study Start: May 23, 2017
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: April 13, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)