Developing and Testing a Comprehensive MS Spasticity Management Program

NCT02170779 | Completed Phase 2 Results

• 1 other identifier: N1401-P
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis; Spasticity

Keywords

multiple sclerosis; spasticity; stretching; exercise; rehabilitation

Outcome Measures

Primary Outcomes (1)

• MS Walking Scale-12 (MSWS-12)

  The MSWS-12 is a clinically validated and reliable tool that is flexible and simple enough to use clinically and in research. It captures patients' perspectives on their ambulatory disability on the following: standing, ability to run, need for support, moving around the home, concentration needed to walk, walking speed, maintaining balance, climbing stairs, walking distance, effort needed to walk, ability to walk, and gait. It is simple to administer and responsive to changes in patient performance over time. Individual items are scored on a 5 point Likert scale: 1 (Not at all), 2 (A little), 3 (Moderately), 4 (Quite a bit), 5 (Extremely). A total score is generated and reported on a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12, or 48), and multiplying. Higher values represent a worse outcome and greater disability.

  at average of 4 months

Secondary Outcomes (8)

• Timed 25 Foot Walk

  at average of 4 months

• Timed up and go Test

  at average of 4 months

• 2 Minute Walk Test

  at average of 4 months

• Modified Fatigue Impact Scale (MFIS)

  at average of 4 months

• Multiple Sclerosis Impact Scale (MSIS-29)

  at average of 4 months

Study Arms (2)

A Spasticity: Take Control

EXPERIMENTAL

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

Behavioral: Spasticity: Take Control

B Usual care

OTHER

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

Other: Usual care

Interventions

Spasticity: Take Control BEHAVIORAL

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

A Spasticity: Take Control

Usual care OTHER

2 visits: baseline followed by usual care of brochure for stretching then outcome measures

B Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Cinda Hugos, Physical Therapist
• Organization: VA Research and Development

hugosc@ohsu.edu

503-220-8262

Study Officials

• Lucinda L Hugos, MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 23, 2014
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 28, 2017
• Results First Posted: March 28, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)