Clinical trial NCT03735654: Multi-joint Muscle Fatigability and Gait Performance in People With Multiple Sclerosis
Official title: Assessing the Impact of Muscle Strength and Fatigability on Gait Performance Using Single Joint and Multi-joint Assessments in People With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Fatigue
Lead sponsor: Washington D.C. Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2018-11-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive care at the Washington DC Veteran's Affairs Medical Center Neurology Service and Multiple Sclerosis Center of Excellence - East

Brief summary: The purpose of this study is to compare walking to leg strength and endurance in people with multiple sclerosis (PwMS). Using these findings, we hope to be better understand what causes PwMS to have problems walking.

Detailed description: The purposes of the research are to determine the association of gait performance with lower extremity muscle fatigability and strength measures, and create a preliminary model that can better explain the variance in gait performance based on these muscle performance values. Objective criterion-based measures of physical fatigue (i.e., fatigability) and muscle weakness have been associated with impaired task performance in people with multiple sclerosis (MS). MS-related deficits in muscle capacity result in higher fall risks and a loss of function. However, it is unclear if lower extremity fatigability tests add clinical value to objective strength testing in the rehabilitation and clinical management of MS. Better understanding how patterns of lower extremity (LE) fatigability and strength affect mobility in people with MS could improve outcome measure development and inform rehabilitation strategies.

Eligibility criteria: Inclusion Criteria:

* Age 18-85 years
* History of multiple sclerosis
* Expanded Disability Status Scale \< 7.0
* Receives care at the Washington DC Veteran's Affairs Medical Center Neurology Service and Multiple Sclerosis Center of Excellence - East

Primary outcomes:
measure: Functional Ambulation Performance (FAP)
timeFrame: 1 Day
measure: Hip, knee, and ankle fatigability
timeFrame: 1 Day
measure: Hip, knee, and ankle maximal volitional contraction
timeFrame: 1 Day
Secondary outcomes:
measure: Adult Myopathy Assessment Tool (AMAT)
timeFrame: 1 Day
measure: 5 times sit to stand test (5STS)
timeFrame: 1 Day
Other outcomes:
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: 1 Day
measure: Fatigue Severity Score (FSS)
timeFrame: 1 Day
measure: Neurology Quality of Life Adult Fatigue Bank (AFB)
timeFrame: 1 Day
measure: Activity Balance Confidence Score (ABC)
timeFrame: 1 Day
measure: BioSensic measure of Reciprocal Compensatory Index (RCI)
timeFrame: 1 Day
measure: Multiple Sclerosis Spasticity Scale (MSSS-88)
timeFrame: 1 Day
measure: Kurtzke Expanded Disability Status Scale (EDSS)
timeFrame: 1 Day
measure: Beck Depression Index II (BDI-II)
timeFrame: 1 Day
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 1 Day
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 1 Day
Locations:
city: Washington
country: United States
facility: Washington DC VA Medical Center
state: District of Columbia
Study officials:
affiliation: Washington DC VA Medical Center
name: Michael Harris-Love, DSc
role: PRINCIPAL_INVESTIGATOR
References: