Clinical trial NCT03166930: Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Official title: Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Muscle Spasticity
Muscle Stretching Exercises
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2017-05-25
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88
timeFrame: One month post-intervention
Secondary outcomes:
measure: Severity of spasticity, measured by the Numeric Rating Scale for Spasticity
timeFrame: One month post-intervention
measure: Fatigue, measured by the Modified Fatigue Impact Scale
timeFrame: One month post-intervention
measure: Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index
timeFrame: One month post-intervention
measure: Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29
timeFrame: One month post-intervention
measure: PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a
timeFrame: One month post-intervention
measure: Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12
timeFrame: One month post-intervention
measure: Walking measured by the Timed 25 Foot Walk
timeFrame: One month post-intervention
measure: Walking and turning measured by the Timed Up and Go
timeFrame: One month post-intervention
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Lucinda L. Hugos, PT MS
role: PRINCIPAL_INVESTIGATOR
References:
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.