Evaluation of a Spasticity Management Program for People With Multiple Sclerosis (NCT03166930) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
United States232 participantsStarted 2018-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Timeframe: One month post-intervention
2
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88