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

March 9, 2026 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Now online since COVID-19

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
232

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • VA Portland Health Care System, Portland, OR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Behavioral: Spasticity Take Control
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
Active Comparator: Stretching for People with MS: An Illustrated Manual
Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management.
Behavioral: Stretching for People with MS: An Illustrated Manual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
One month post-intervention
Impact of Spasticity, Measured by the Multiple Sclerosis Spasticity Scale-88
Time Frame: Six months post-intervention
Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at six months post intervention. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.
Six months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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. Minimum score = 0. Maximum score = 10. A higher score is a worse outcome.
One month post-intervention
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. Minimum score = 0. Maximum score = 84. A higher score is a worse outcome.
One month post-intervention
Sleep Quality and Quantity, Measured by the Pittsburgh 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. Minimum score = 0. Maximum score = 21. A higher score is a worse outcome.
One month post-intervention
Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-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. The 29-item self-report measures the physical and psychological impact of MS from the patient's perspective through two subscales. The 29 items are divided into a 20 item physical scale and 9 item psychological scale, with each each scored between 1 (not at all impactful) and 5 (extremely impactful). Totaled minimum score = 29. Totaled maximum score = 145. The Psychological subscale (9 items) ranging from 9 to 45, and the Physical subscale (20 items) ranging from 20 to 100. A higher score is a worse outcome.
One month post-intervention
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. Minimum score = 8. Maximum score = 40. A higher score is a worse outcome.
One month post-intervention
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. Minimum score = 12. Maximum score = 60. A higher score is a worse outcome.
One month post-intervention
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, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.
One month post-intervention
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, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.
One month post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lucinda L. Hugos, PT MS, VA Portland Health Care System, Portland, OR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2507-R
  • I01RX002507 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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