Multiple Sclerosis Clinical Trial
— STCOfficial title:
Evaluation of a Spasticity Management Program for People With Multiple Sclerosis
Verified date | July 2022 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 231 |
Est. completion date | January 31, 2022 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Portland Health Care System, Portland, OR | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One month post-intervention | |
Secondary | 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. | One month post-intervention | |
Secondary | Fatigue, measured by the Modified Fatigue Impact Scale | Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention. | One month post-intervention | |
Secondary | Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index | Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention. | One month post-intervention | |
Secondary | Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 | Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention. | One month post-intervention | |
Secondary | 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. | One month post-intervention | |
Secondary | 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. | One month post-intervention | |
Secondary | 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. | One month post-intervention | |
Secondary | 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. | One month post-intervention |
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