Multiple SclerosisMS_GaitNCT03735654
Multi-joint Muscle Fatigability and Gait Performance in People With Multiple Sclerosis
An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic, Fatigue
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who receive care at the Washington DC Veteran's Affairs Medical Center Neurology Service and Multiple Sclerosis Center of Excellence - East
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center
Washington D.C., District of Columbia, 20422
Kimberly Benson, DPT, 202-745-8000 ext. 55852, Kimberly.Benson2@va.gov
Brian M Hoover, MS, 202-745-8000 ext. 55826, Brian.Hoover@va.gov
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic, Fatigue
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Performance (FAP)
The FAP is used to quantify self-selected gait.
Measured: 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.
Measured: 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.
Measured: 1 Day
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Nov 2018 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington D.C. Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center
- Investigators
- Michael Harris-Love, DSc, Principal investigator, Washington DC VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735654
- Sponsor's protocol ID
- 01931
- Acronym
- MS_Gait
- Status last verified
- Nov 2018
- First submitted
- 3 Oct 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03735654
- Acronym / sponsor ID
- MS_Gait / 01931
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic, Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Washington D.C. Veterans Affairs Medical CenterUS federal agency
- Study start
- 15 Nov 2018 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 8 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive care at the Washington DC Veteran's Affairs Medical Center Neurology Service and Multiple Sclerosis Center of Excellence - East
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Adult Myopathy Assessment Tool (AMAT)
Time frame: 1 Day
5 times sit to stand test (5STS)
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harris-Love, DSc principal investigator
Washington DC VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by Washington D.C. Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Harris-Love, DSc ((202) 745-8240, michael.harris-love@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Ambulation Performance (FAP) (time frame: 1 Day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.