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
|Condition or disease|
|Multiple Sclerosis Gait Disorders, Neurologic Fatigue|
|Study Type :||Observational|
|Estimated Enrollment :||35 participants|
|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|
- Functional Ambulation Performance (FAP) [ Time Frame: 1 Day ]The FAP is used to quantify self-selected gait.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Beck Depression Index II (BDI-II) [ Time Frame: 1 Day ]The BDI-II is a widely used test for measuring depression among individuals.
- 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.
- 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.
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
|Contact: Michael Harris-Love, DSc||(202) firstname.lastname@example.org|
|Contact: Kimberly Benson, DPT||(202) 745-8000 ext 55852||Kimberly.Benson2@va.gov|
|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|
|Principal Investigator:||Michael Harris-Love, DSc||Washington DC VA Medical Center|