Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 232
- Locations
- 1
- Primary Endpoint
- Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Study Overview
Brief 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.
Detailed Description
Now online since COVID-19
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Intervention: Spasticity Take Control (Behavioral)
Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Intervention: Stretching for People with MS: An Illustrated Manual (Behavioral)
Outcomes
Primary Outcomes
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Time Frame: One month post-intervention
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Time Frame: Six months post-intervention
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at six months post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Secondary Outcomes
- PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a(One month post-intervention)
- Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity(One month post-intervention)
- Fatigue, Measured by the Modified Fatigue Impact Scale(One month post-intervention)
- Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index(One month post-intervention)
- Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)(One month post-intervention)
- Impact on Multiple Sclerosis on Walking, Measured by the Multiple Sclerosis Walking Scale-12(One month post-intervention)
- Walking Measured by the Timed 25 Foot Walk(One month post-intervention)
- Walking and Turning Measured by the Timed Up and Go(One month post-intervention)