Strength Training to Improve Gait in People With Multiple Sclerosis

NCT ID: NCT03175133

Last Updated: 2018-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-23
• Study Completion Date: 2017-11-08

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Strength exercise

Intervention Type: OTHER

Strengthening exercises performed with physical therapist.

Interventions

Strength exercise

Strengthening exercises performed with physical therapist.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Schenkman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 29070966 (View on PubMed)

Other Identifiers

16-2610

Identifier Type: -

Identifier Source: org_study_id