N/A
N=231
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03166930 ↗Enrolled (actual)
231
Serious AEs
3.0%
Results posted
Mar 2026
Primary outcome: Primary: Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 — -16.11; -15.83 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spasticity Take Control (Behavioral); Stretching for People with MS: An Illustrated Manual (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 |
-23.25; -24.11 | — |
| PRIMARY Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88 |
-23.25; -24.11 | — |
| SECONDARY Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity |
-0.41; -0.45 | — |
| SECONDARY Fatigue, Measured by the Modified Fatigue Impact Scale |
-6.24; -5.16 | — |
| SECONDARY Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index |
-0.69; -0.31 | — |
| SECONDARY Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29) |
-5.01; -4.74; -4.61; -5.94 | — |
| SECONDARY PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a |
-1.61; -0.86 | — |
| SECONDARY Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12 |
-3.67; -4.93 | — |
| SECONDARY Walking Measured by the Timed 25 Foot Walk |
1.18; 0.10 | — |
| SECONDARY Walking and Turning Measured by the Timed Up and Go |
0.68; 0.48 | — |
Summary
This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.
Eligibility Criteria
Inclusion Criteria
- A diagnosis of definite MS by 2010 updated McDonald Criteria
- Age 18 or older
- Able to walk 25 feet with any assistive devices (Patient Determined Disease Steps 0-6)
- Fluent in written and spoken English, as materials are not validated in languages other than English.
- Presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: Have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up.
- All women that meet the above criteria
- Only Veteran men that meet the above criteria
Exclusion Criteria
- Any uncontrolled medical or mental condition that would limit participation or completion of the study
- Any self-reported musculoskeletal or neurological condition other than MS that is known to cause spasticity
Data sourced from ClinicalTrials.gov (NCT03166930). 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.