Developing and Testing a Comprehensive MS Spasticity Management Program
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- MS Walking Scale-12 (MSWS-12)
Study Overview
Brief Summary
This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.
Detailed Description
Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of definite MS
- •At least 18 years old
- •Able to walk 25 feet independently with common assistive devices if needed
- •Presence of spasticity by self-report interfering with usual daily activities
- •Have an email account and be familiar with using it
- •Willing to track daily exercise for 4 weeks
- •Fluent in English
Exclusion Criteria
- •Other medical or behavioral conditions that would limit participation or completion of the study.
Arms & Interventions
A Spasticity: Take Control
4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
Intervention: Spasticity: Take Control (Behavioral)
B Usual care
2 visits: baseline and given usual treatment of brochure for stretching, outcome measures
Intervention: Usual care (Other)
Outcomes
Primary Outcomes
MS Walking Scale-12 (MSWS-12)
Time Frame: at average of 4 months
The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.
Secondary Outcomes
- Timed 25 Foot Walk(at average of 4 months)
- Timed up and go Test(at average of 4 months)
- 2 Minute Walk Test(at average of 4 months)
- Modified Fatigue Impact Scale (MFIS)(at average of 4 months)
- Multiple Sclerosis Impact Scale (MSIS-29)(at average of 4 months)
- Spasticity Measured by the Modified Ashworth Scale(at average of 4 months)
- Multiple Sclerosis Spasticity Scale - 88 (MSSS-88)(at average of 4 months)
- Beck Depression Inventory II (BDI II)(at average of 4 months)