Developing and Testing a Comprehensive MS Spasticity Management Program

VA Office of Research and Development

Status and phase: Completed; Phase 2

Conditions: Spasticity; Multiple Sclerosis

Treatments: Behavioral: Spasticity: Take Control; Other: Usual care

Study type: Interventional

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

Identifiers

NCT02170779

N1401-P

Details and patient eligibility

About

This is a study to determine the impact of education and specific lower extremity stretches for MS-related spasticity. The study will evaluate the acceptance and efficacy of education and stretching using a randomized controlled pilot trial.

Full description

Participants have 2-4 visits depending on program assignment. All participants will have screening/baseline and follow-up visits. Participants in the intervention program will have 2 additional visits with a group of other people with MS to view and discuss the DVDs on spasticity education and stretching for lower extremity MS spasticity and then practice the stretching exercises learned. They will be asked to track exercise electronically and on paper for 4 weeks. Participants will be compensated for participation.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Diagnosis of definite MS

• At least 18 years old
• Able to walk 25 feet independently with common assistive devices if needed
• Presence of spasticity by self-report interfering with usual daily activities
• Have an email account and be familiar with using it
• Willing to track daily exercise for 4 weeks
• Fluent in English

Exclusion criteria

Other medical or behavioral conditions that would limit participation or completion of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

A Spasticity: Take Control

Experimental group

Description:

4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures

Treatment:

Behavioral: Spasticity: Take Control

B Usual care

Other group

Description:

2 visits: baseline and given usual treatment of brochure for stretching, outcome measures

Treatment:

Other: Usual care