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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spasticity Take Control
Stretching for People with MS: An Illustrated Manual
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Muscle Spasticity, Muscle Stretching Exercises

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Portland Health Care System, Portland, OR

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spasticity Take Control

Stretching for People with MS: An Illustrated Manual

Arm 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.

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

Outcomes

Primary Outcome Measures

Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.

Secondary Outcome Measures

Severity of spasticity, measured by the Numeric Rating Scale for Spasticity
Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention.
Fatigue, measured by the Modified Fatigue Impact Scale
Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention.
Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index
Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention.
Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29
Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention.
PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention.
Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12
Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention.
Walking measured by the Timed 25 Foot Walk
Walking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person.
Walking and turning measured by the Timed Up and Go
Walking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person.

Full Information

First Posted
May 19, 2017
Last Updated
July 15, 2022
Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03166930
Brief Title
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Acronym
STC
Official Title
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Oregon Health and Science University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 via video teleconference in group classes consisting of exercises to reduce spasticity.
Detailed Description
Now online since COVID-19

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Muscle Spasticity, Muscle Stretching Exercises

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spasticity Take Control
Arm Type
Experimental
Arm 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.
Arm Title
Stretching for People with MS: An Illustrated Manual
Arm Type
Active Comparator
Arm Description
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Intervention Type
Behavioral
Intervention Name(s)
Spasticity Take Control
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Stretching for People with MS: An Illustrated Manual
Intervention Description
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
Primary Outcome Measure Information:
Title
Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88
Description
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.
Time Frame
One month post-intervention
Secondary Outcome Measure Information:
Title
Severity of spasticity, measured by the Numeric Rating Scale for Spasticity
Description
Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention.
Time Frame
One month post-intervention
Title
Fatigue, measured by the Modified Fatigue Impact Scale
Description
Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention.
Time Frame
One month post-intervention
Title
Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index
Description
Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention.
Time Frame
One month post-intervention
Title
Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29
Description
Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention.
Time Frame
One month post-intervention
Title
PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
Description
Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention.
Time Frame
One month post-intervention
Title
Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12
Description
Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention.
Time Frame
One month post-intervention
Title
Walking measured by the Timed 25 Foot Walk
Description
Walking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person.
Time Frame
One month post-intervention
Title
Walking and turning measured by the Timed Up and Go
Description
Walking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person.
Time Frame
One month post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucinda L. Hugos, PT MS
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33028236
Citation
Hugos CL, Cameron MH. MS Spasticity: Take Control (STC) for ambulatory adults: protocol for a randomized controlled trial. BMC Neurol. 2020 Oct 7;20(1):368. doi: 10.1186/s12883-020-01902-1.
Results Reference
derived

Learn more about this trial

Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

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