Evaluation of a Spasticity Management Program for People With Multiple Sclerosis (STC)

VA Office of Research and Development

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Stretching for People with MS: An Illustrated Manual; Behavioral: Spasticity Take Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03166930

I01RX002507 (U.S. NIH Grant/Contract)

B2507-R

Details and patient eligibility

About

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.

Full description

Now online since COVID-19

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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231 participants in 2 patient groups

Spasticity Take Control

Experimental group

Description:

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

Treatment:

Behavioral: Spasticity Take Control

Stretching for People with MS: An Illustrated Manual

Active Comparator group

Description:

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

Treatment:

Behavioral: Stretching for People with MS: An Illustrated Manual