NCT03735654

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

1.9 years

First QC Date

October 3, 2018

Last Update Submit

November 7, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Adult Myopathy Assessment Tool (AMAT)

    1 Day

  • 5 times sit to stand test (5STS)

    1 Day

Other Outcomes (10)

  • Modified Fatigue Impact Scale (MFIS)

    1 Day

  • Fatigue Severity Score (FSS)

    1 Day

  • Neurology Quality of Life Adult Fatigue Bank (AFB)

    1 Day

  • +7 more other outcomes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

MeSH Terms

Conditions

Multiple SclerosisGait Disorders, NeurologicFatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Harris-Love, DSc

    Washington DC VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Harris-Love, DSc

CONTACT

Kimberly Benson, DPT

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, 3MAP Lab, and Assoc. Director, CRC Human Performance Research Unit

Study Record Dates

First Submitted

October 3, 2018

First Posted

November 8, 2018

Study Start

November 15, 2018

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

November 8, 2018

Record last verified: 2018-11

Locations