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Completed

NCT Number: NCT03166930

Evaluation of a Spasticity Management Program for People With Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

About this study

Now online since COVID-19

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  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. Minimum score = 88. Maximum score = 352. A higher score is a worse outcome.

  2. 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.

Secondary outcomes

  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. Minimum score = 0. Maximum score = 10. A higher score is a worse outcome.

  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. Minimum score = 0. Maximum score = 84. A higher score is a worse outcome.

  3. 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.

  4. 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.

  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. Minimum score = 8. Maximum score = 40. A higher score is a worse outcome.

  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. Minimum score = 12. Maximum score = 60. A higher score is a worse outcome.

  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, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.

  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, only if visit is in person. No scale - continuous measure. A higher score is a worse outcome.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Acronym: STC

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 25, 2017
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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