Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Spasticity Take Control

• Registration Number: NCT03166930
• Lead Sponsor: VA Office of Research and Development

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 Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-25
• Study Start: 2018-01-01
• Primary Completion: 2021-07-30
• Study Completion: 2022-01-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-15
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spasticity Take Control	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.

Primary Outcome Measures

Name	Time	Method
Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88	One month post-intervention	Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States