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

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ClinicalTrials.gov Identifier: NCT03735654
Recruitment Status : Not yet recruiting
First Posted : November 8, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Harris-Love, 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.

Condition or disease
Multiple Sclerosis Gait Disorders, Neurologic Fatigue

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.

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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : November 15, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Functional Ambulation Performance (FAP) [ Time Frame: 1 Day ]
    The FAP is used to quantify self-selected gait.

  2. Hip, knee, and ankle fatigability [ Time Frame: 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.

  3. Hip, knee, and ankle maximal volitional contraction [ Time Frame: 1 Day ]
    Maximal volitional contraction will be measured by the load cell using isometric expressed as peak torque.


Secondary Outcome Measures :
  1. Adult Myopathy Assessment Tool (AMAT) [ Time Frame: 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.

  2. 5 times sit to stand test (5STS) [ Time Frame: 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.


Other Outcome Measures:
  1. Modified Fatigue Impact Scale (MFIS) [ Time Frame: 1 Day ]
    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.

  2. Fatigue Severity Score (FSS) [ Time Frame: 1 Day ]
    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.

  3. Neurology Quality of Life Adult Fatigue Bank (AFB) [ Time Frame: 1 Day ]
    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.

  4. Activity Balance Confidence Score (ABC) [ Time Frame: 1 Day ]
    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.

  5. BioSensic measure of Reciprocal Compensatory Index (RCI) [ Time Frame: 1 Day ]
    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.

  6. Multiple Sclerosis Spasticity Scale (MSSS-88) [ Time Frame: 1 Day ]
    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.

  7. Kurtzke Expanded Disability Status Scale (EDSS) [ Time Frame: 1 Day ]
    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.

  8. Beck Depression Index II (BDI-II) [ Time Frame: 1 Day ]
    The BDI-II is a widely used test for measuring depression among individuals.

  9. Epworth Sleepiness Scale (ESS) [ Time Frame: 1 Day ]
    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.

  10. Montreal Cognitive Assessment (MoCA) [ Time Frame: 1 Day ]
    The MoCA is a subject questionnaire that can be used as a screening tool for cognitive dysfunction in people with MS.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735654


Contacts
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Contact: Michael Harris-Love, DSc (202) 745-8240 michael.harris-love@va.gov
Contact: Kimberly Benson, DPT (202) 745-8000 ext 55852 Kimberly.Benson2@va.gov

Locations
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United States, District of Columbia
Washington DC VA Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20422
Contact: Kimberly Benson, DPT    202-745-8000 ext 55852    Kimberly.Benson2@va.gov   
Contact: Brian M Hoover, MS    202-745-8000 ext 55826    Brian.Hoover@va.gov   
Principal Investigator: Michael Harris-Love, DSc         
Sub-Investigator: Marc Blackman, MD         
Sub-Investigator: Kimberly Benson, DPT         
Sub-Investigator: Mitchell Wallin, MD         
Sub-Investigator: Heidi Maloni, PhD, MSN         
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
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Principal Investigator: Michael Harris-Love, DSc Washington DC VA Medical Center

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Responsible Party: Michael Harris-Love, Director, 3MAP Lab, and Assoc. Director, CRC Human Performance Research Unit, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03735654     History of Changes
Other Study ID Numbers: 01931
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Fatigue
Nervous System Diseases
Gait Disorders, Neurologic
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms
Neurologic Manifestations