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

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: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Spasticity Take Control; Behavioral: Stretching for People with MS: An Illustrated Manual

Detailed Description

Now online since COVID-19

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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. 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	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

Outcome Measure	Measure Description	Time Frame
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. 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	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	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)	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	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	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	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	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

• Sponsor: VA Office of Research and Development
• Collaborators: Oregon Health and Science University
• Investigators: Principal Investigator: Lucinda L. Hugos, PT MS, VA Portland Health Care System, Portland, OR

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Muscle Stretching Exercises; Muscle Spasticity
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Multiple Sclerosis
• Other Study ID 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