Evaluation of a Spasticity Management Program for People With Multiple Sclerosis


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Verified May 2017 by VA Office of Research and Development

Sponsor:

Collaborator:

Oregon Health and Science University

Information provided by (Responsible Party):

VA Office of Research and Development

ClinicalTrials.gov Identifier:

NCT03166930

First received: May 19, 2017

Last updated: May 23, 2017

Last verified: May 2017

This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented as group classes consisting of exercises to reduce spasticity. One program consists of stretching exercises, while the other consists primarily of range-of-motion and strengthening exercises.

Multiple Sclerosis Behavioral: Spasticity Take Control
Behavioral: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Participants will be randomized to receive one of two exercise programs. The intervention group will receive “Spasticity Take Control,” which will consist of a stretching program designed by the principal investigator. The other group will receive an exercise program based on usual care, which will consist of exercises taken from the National MS Society brochure, “Stretching for People with MS: An Illustrated Manual.” 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.

Masking: Outcomes Assessor
Primary Purpose: Supportive Care

Official Title: Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

Primary Outcome Measures:

Secondary Outcome Measures:

  • Severity of spasticity [ Time Frame: One month post-intervention ]

    Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention.

  • Fatigue [ Time Frame: One month post-intervention ]

    Fatigue will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on fatigue at one month post intervention.

  • Sleep quality and quantity [ Time Frame: One month post-intervention ]

    Sleep quality and quantity will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on sleep at one month post intervention.

  • Physical function [ Time Frame: One month post-intervention ]

    Physical function will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on physical function at one month post intervention.

  • Self-efficacy [ Time Frame: One month post-intervention ]

    Self-efficacy will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on self-efficacy at one month post intervention.

  • Social participation [ Time Frame: One month post-intervention ]

    Social participation will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on social participation at one month post intervention.

  • Social satisfaction [ Time Frame: One month post-intervention ]

    Social satisfaction will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on social satisfaction at one month post intervention.

  • Perception of global health [ Time Frame: One month post-intervention ]

    Perception of global health will be measured using the NIH Patient Reported Outcomes Measurement Information System (PROMIS) questionnaire on perception of global health at one month post intervention.

Estimated Enrollment: 220
Anticipated Study Start Date: October 2, 2017
Estimated Study Completion Date: April 1, 2021
Estimated Primary Completion Date: April 1, 2020 (Final data collection date for primary outcome measure)
Experimental: Spasticity Take Control

Participants will attend two 2-hour classes, one week apart, consisting of a stretching program developed by the principal investigator for spasticity management.

Behavioral: Spasticity Take Control

Participants will attend two 2-hour classes, one week apart, consisting of a stretching program developed by the principal investigator for spasticity management.

Active Comparator: Usual care

Participants will attend two 2-hour classes, one week apart, consisting of exercises as outlined in the National MS Society brochure, ?Stretching for People with MS: An Illustrated Manual.?

Behavioral: Usual care

Participants will attend two 2-hour classes, one week apart, consisting of exercises as outlined in the National MS Society brochure, “Stretching for People with MS: An Illustrated Manual.”

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A diagnosis of definite MS by 2010 updated McDonald Criteria
  • Able to walk 60 feet with any assistive devices (Expanded Disability Status Scale (EDSS) <7.0)
  • 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, using the NARCOMS definition
  • Willing to not change spasticity medications during the study.

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
  • Presently receiving physical therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03166930

VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
Contact: Lucinda L Hugos, PT MS    503-220-8262 ext 52338    cinda.hugos@va.gov   
Principal Investigator: Lucinda L. Hugos, PT MS         

VA Office of Research and Development

Oregon Health and Science University

Principal Investigator: Lucinda L. Hugos, PT MS VA Portland Health Care System, Portland, OR

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03166930     History of Changes
Other Study ID Numbers: B2507-R
I01 RX002507 ( Other Grant/Funding Number: US Department of Veterans Affairs )
Study First Received: May 19, 2017
Last Updated: May 23, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

Muscle Spasticity
Muscle Stretching Exercises

Additional relevant MeSH terms:

Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
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

ClinicalTrials.gov processed this record on May 25, 2017