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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03735654
Acronym
MS_Gait
Enrollment
35
Registered
2018-11-08
Start date
2018-11-15
Completion date
2021-10-01
Last updated
2018-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Gait Disorders, Neurologic, Multiple Sclerosis

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.

Interventions

None listed

Sponsors

Washington D.C. Veterans Affairs Medical Center
Lead SponsorFED

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Ambulation Performance (FAP)1 DayThe FAP is used to quantify self-selected gait.
Hip, knee, and ankle fatigability1 DayFor 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 contraction1 DayMaximal volitional contraction will be measured by the load cell using isometric expressed as peak torque.

Secondary

MeasureTime frameDescription
Adult Myopathy Assessment Tool (AMAT)1 DayThe 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 DayThe 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.

Other

MeasureTime frameDescription
Multiple Sclerosis Spasticity Scale (MSSS-88)1 DayThe 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.
Kurtzke Expanded Disability Status Scale (EDSS)1 DayThis 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.
Modified Fatigue Impact Scale (MFIS)1 DayThe 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.
Epworth Sleepiness Scale (ESS)1 DayThe ESS is a subjective questionnaire that measures sleep disturbances and excessive sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.
Montreal Cognitive Assessment (MoCA)1 DayThe MoCA is a subject questionnaire that can be used as a screening tool for cognitive dysfunction in people with MS.
Beck Depression Index II (BDI-II)1 DayThe BDI-II is a widely used test for measuring depression among individuals.
Fatigue Severity Score (FSS)1 DayThe 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.
Neurology Quality of Life Adult Fatigue Bank (AFB)1 DayThe 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.
Activity Balance Confidence Score (ABC)1 DayThe 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.
BioSensic measure of Reciprocal Compensatory Index (RCI)1 DayBalanSens 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.

Countries

United States

Contacts

Primary ContactMichael Harris-Love, DSc
michael.harris-love@va.gov(202) 745-8240
Backup ContactKimberly Benson, DPT
Kimberly.Benson2@va.gov(202) 745-8000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026