Clinical trial NCT03175133: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: rehabilitation
physical therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Muscle Strength
timeFrame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
measure: Change in Timed 25 Foot Walk (T25FW)
timeFrame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
Secondary outcomes:
measure: Change in 6-Minute Walk Test
timeFrame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
measure: Change in Dynamic Gait Index
timeFrame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
measure: Change in Multiple Sclerosis Walking Scale-12
timeFrame: Week 0 (Baseline 1); Week 1 (Baseline 2); Week 10 (Follow-Up)
measure: Change in Patient Specific Functional Scale
timeFrame: Week 0 (Baseline 1); Week 10 (Follow-Up)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Margaret Schenkman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.