Phase 2
N=40
Developing and Testing a Comprehensive MS Spasticity Management Program
Multiple Sclerosis · Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT02170779 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: MS Walking Scale-12 (MSWS-12) — 72.6; 82.2 units on a scale — p=0.84
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Spasticity: Take Control (Behavioral); Usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MS Walking Scale-12 (MSWS-12) |
72.6; 82.2 | 0.84 |
| SECONDARY Timed 25 Foot Walk |
7.6; 9.4 | 0.738 |
| SECONDARY Timed up and go Test |
11.23; 13.82 | 0.8434 |
| SECONDARY 2 Minute Walk Test |
462.8; 412.5 | 0.638 |
| SECONDARY Modified Fatigue Impact Scale (MFIS) |
41.1; 43.5 | 0.492 |
| SECONDARY Multiple Sclerosis Impact Scale (MSIS-29) |
45.6; 52.4; 18.2; 20.6 | 0.144 |
| SECONDARY Spasticity Measured by the Modified Ashworth Scale |
10.8; 10.8 | 0.915 |
| SECONDARY Multiple Sclerosis Spasticity Scale - 88 (MSSS-88) |
165.7; 192.4 | 0.023 sig |
| SECONDARY Beck Depression Inventory II (BDI II) |
9; 11.5 | 0.11 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02170779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.