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

Assessing the Impact of Muscle Strength and Fatigability on Gait Performance Using Single Joint and Multi-joint Assessments in People With Multiple Sclerosis

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 35

Contacts and Locations

• Study Contact: Name: Michael Harris-Love, DSc; Phone Number: (202) 745-8240; Email: michael.harris-love@va.gov
• Study Contact Backup: Name: Kimberly Benson, DPT; Phone Number: 55852 (202) 745-8000; Email: Kimberly.Benson2@va.gov

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Washington DC VA medical Center
      • Contact: Kimberly Benson, DPT; Phone Number: 55852 202-745-8000; Email: Kimberly.Benson2@va.gov
      • Sub-Investigator: Kimberly Benson, DPT
      • Sub-Investigator: Mitchell Wallin, MD
      • Sub-Investigator: Heidi Maloni, PhD, MSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulation Performance (FAP)	The FAP is used to quantify self-selected gait.	1 Day
Hip, knee, and ankle fatigability	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.	1 Day
Hip, knee, and ankle maximal volitional contraction	Maximal volitional contraction will be measured by the load cell using isometric expressed as peak torque.	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Myopathy Assessment Tool (AMAT)	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.	1 Day
5 times sit to stand test (5STS)	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.	1 Day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Fatigue Impact Scale (MFIS)	The MFIS is based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items and is a subscale of the MS Quality of Life Inventory.	1 Day
Fatigue Severity Score (FSS)	The FSS is a questionnaire that can indicate severe fatigue related to MS. Scores range from 9-63 with higher scores indicating higher levels of fatigue.	1 Day
Neurology Quality of Life Adult Fatigue Bank (AFB)	The AFB measures are a collection of patient- reported questionnaires and short forms developed with the goal of assessing health-related quality of life (HRQL) across all neurological disorders.	1 Day
Activity Balance Confidence Score (ABC)	The ABC Scale is a 16-item questionnaire that serves as a rating of self-perceived confidence during performance of activities of daily living. Scores range from 0-100 with higher scores indicating greater confidence.	1 Day
BioSensic measure of Reciprocal Compensatory Index (RCI)	BalanSens is a biosensor and is based on widely-available kinematic sensors (i.e. accelerometer, gyroscope and magnetometer). The system measures ankle and hip motion in three dimensions. It allows for object measurement of balance when a patient performs Romberg, sharpened Romberg eyes open and closed and single leg stance.	1 Day
Multiple Sclerosis Spasticity Scale (MSSS-88)	The MSSS-88 is a subjective assessment of day-to-day spasticity symptoms and functional impact in eight clinically separate areas. Scores range from 88-352 and higher scores indicate greater spasticity.	1 Day
Kurtzke Expanded Disability Status Scale (EDSS)	This is a standardized neurological disability scale developed specifically for MS. It accounts broadly for MS symptoms, including things like mobility, mental health, and sensory disturbances. Scores range from 0-10 with higher scores indicating loss of ambulatory ability.	1 Day
Beck Depression Index II (BDI-II)	The BDI-II is a widely used test for measuring depression among individuals.	1 Day
Epworth Sleepiness Scale (ESS)	The ESS is a subjective questionnaire that measures sleep disturbances and excessive sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.	1 Day
Montreal Cognitive Assessment (MoCA)	The MoCA is a subject questionnaire that can be used as a screening tool for cognitive dysfunction in people with MS.	1 Day

Collaborators and Investigators

• Sponsor: Washington D.C. Veterans Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 15, 2018
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2021

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (ACTUAL): November 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 7, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 01931

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No