Strength Training to Improve Gait in People With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175133
• Other study ID #: 16-2610
• Status: Completed
• Phase: N/A
• First received: May 23, 2017
• Last updated: April 11, 2018
• Start date: May 23, 2017
• Est. completion date: November 8, 2017

Study information

• Verified date: April 2018
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 8, 2017
• Est. primary completion date: November 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Strength exercise
Strengthening exercises performed with physical therapist.

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mañago 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Change in 6-Minute Walk Test	Gait endurance	Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Secondary	Change in Dynamic Gait Index	Balance during gait and other functional activities	Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Secondary	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)
Secondary	Change in Patient Specific Functional Scale	Self reported measure of self-selected limitations in participation	Week 0 (Baseline 1); Week 10 (Follow-Up)

External Links

•   Link to publication