Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-01-31

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.

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Detailed Description

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Now online since COVID-19

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Spasticity Take Control

Intervention Type BEHAVIORAL

Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.

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.

Group Type ACTIVE_COMPARATOR

Stretching for People with MS: An Illustrated Manual

Intervention Type BEHAVIORAL

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.

Interventions

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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 Type 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 from the manual.

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No