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

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ClinicalTrials.gov Identifier: NCT03166930
Recruitment Status : Recruiting
First Posted : May 25, 2017
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Spasticity Take Control Behavioral: Stretching for People with MS: An Illustrated Manual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spasticity Take Control
Participants will attend two 2-hour classes, one week apart, consisting of a stretching program for spasticity management.
Behavioral: Spasticity Take Control
Participants will attend two 2-hour classes, one week apart, consisting of a stretching program for spasticity management.

Active Comparator: Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes, one week apart, consisting of exercises for spasticity management from the manual.
Behavioral: Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes, one week apart, consisting of exercises for spasticity management from the manual.




Primary Outcome Measures :
  1. Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88 [ Time Frame: One month post-intervention ]
    Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.


Secondary Outcome Measures :
  1. Severity of spasticity, measured by the Numeric Rating Scale for 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.

  2. Fatigue, measured by the Modified Fatigue Impact Scale [ Time Frame: One month post-intervention ]
    Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention.

  3. Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index [ Time Frame: One month post-intervention ]
    Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention.

  4. Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 [ Time Frame: One month post-intervention ]
    Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention.

  5. PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a [ Time Frame: One month post-intervention ]
    Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention.

  6. Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 [ Time Frame: One month post-intervention ]
    Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention.

  7. Walking measured by the Timed 25 Foot Walk [ Time Frame: One month post-intervention ]
    Walking will be measured using the Timed 25 Foot Walk at one month post intervention.

  8. Walking and turning measured by the Timed Up and Go [ Time Frame: One month post-intervention ]
    Walking and turning measured by the Timed Up and Go will be measured at one month post intervention.



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

Inclusion Criteria:

  • A diagnosis of definite MS by 2010 updated McDonald Criteria
  • 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, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03166930


Contacts
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Contact: Sandra K Joos, PhD MPH (503) 220-8262 ext 58329 sandra.joos@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
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         
Sponsors and Collaborators
VA Office of Research and Development
Oregon Health and Science University
Investigators
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Principal Investigator: Lucinda L. Hugos, PT MS VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03166930     History of Changes
Other Study ID Numbers: B2507-R
I01RX002507 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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