Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

NCT03166930 | Completed Results

• 2 other identifiers: B2507-RI01RX002507
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Muscle Spasticity; Muscle Stretching Exercises

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Severity of Spasticity, Measured by the Numeric Rating Scale for Spasticity

  One month post-intervention

• Fatigue, Measured by the Modified Fatigue Impact Scale

  One month post-intervention

• Sleep Quality and Quantity, Measured by the Pittsburgh Sleep Quality Index

  One month post-intervention

• Psychological and Physical Impact on Day-to-day Life, Measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29)

  One month post-intervention

• PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a

  One month post-intervention

Study Arms (2)

Spasticity Take Control

EXPERIMENTAL

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

Stretching for People with MS: An Illustrated Manual

ACTIVE COMPARATOR

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

Interventions

Spasticity Take Control BEHAVIORAL

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

Spasticity Take Control

Stretching for People with MS: An Illustrated Manual BEHAVIORAL

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.

Stretching for People with MS: An Illustrated Manual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 33028236 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Cinda Hugos
• Organization: VAPORHCS

2cinda@gmail.com

5038050269

Study Officials

• Lucinda L. Hugos, PT MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 25, 2017
• Study Start: January 1, 2018
• Primary Completion: July 30, 2021
• Study Completion: January 31, 2022
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)