Multi-joint Muscle Fatigability and Gait Performance in People With Multiple Sclerosis

• Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Fatigue

• Registration Number: NCT03735654
• Lead Sponsor: Washington D.C. Veterans Affairs Medical Center

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.

Study Timeline

• Study First Submitted: 2018-10-03
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-07
• Last Update Submitted: 2018-11-07
• Study First Posted: 2018-11-08
• Last Update Posted: 2018-11-08
• Study Start: 2018-11-15
• Primary Completion: 2020-10-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Performance (FAP)	1 Day	The FAP is used to quantify self-selected gait.
Hip, knee, and ankle fatigability	1 Day	For isometric tests, a exhaustion time will be calculated by determining the time that peak impulse declines to 50% using a method validated for individual with MS.
Hip, knee, and ankle maximal volitional contraction	1 Day	Maximal volitional contraction will be measured by the load cell using isometric expressed as peak torque.

Secondary Outcome Measures

Name	Time	Method
Adult Myopathy Assessment Tool (AMAT)	1 Day	The Adult Myopathy Assessment Tool (0-45 score) is a physical test battery used to evaluate functional performance in individuals with neuromuscular disease. The test consists of 13 measures for functional mobility, balance, strength and endurance to mimic activities of daily living.
5 times sit to stand test (5STS)	1 Day	The 5STS reflects the amount of time required for a participant to complete 5 sit to stand maneuvers without using their hands. For this study we used the 5STS as a measure of functional capacity in people with multiple sclerosis.

Trial Locations

Locations (1)

Washington DC VA Medical Center; 🇺🇸 Washington, District of Columbia, United States