Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Study Overview
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Brief Summary
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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
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Now online since COVID-19

Official Title
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Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Spasticity Take Control
* Behavioral: Stretching for People with MS: An Illustrated Manual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive one of two exercise programs. Participants will not be masked regarding which group they are in, but they will not be told which group is considered standard of care and which is the intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spasticity Take Control<br>Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management. | Behavioral: Spasticity Take Control<br>* Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.<br>|
| Active Comparator: Stretching for People with MS: An Illustrated Manual<br>Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management. | Behavioral: Stretching for People with MS: An Illustrated Manual<br>* Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88 | Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention. | One month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of spasticity, measured by the Numeric Rating Scale for Spasticity | Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention. | One month post-intervention | 
| Fatigue, measured by the Modified Fatigue Impact Scale | Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention. | One month post-intervention | 
| Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index | Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention. | One month post-intervention | 
| Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 | Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention. | One month post-intervention | 
| PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a | Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention. | One month post-intervention | 
| Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 | Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention. | One month post-intervention | 
| Walking measured by the Timed 25 Foot Walk | Walking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person. | One month post-intervention | 
| Walking and turning measured by the Timed Up and Go | Walking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person. | One month post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle Spasticity, Muscle Stretching Exercises