NCT06516458

Brief Summary

The purpose of this study is to develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Jul 2024Jul 2026

Study Start

First participant enrolled

July 1, 2024

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

1 year

First QC Date

July 18, 2024

Last Update Submit

July 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Kinematics of the gait cycle

    Joint position of lower limbs during a single cycle of gait

    at the time of session

Secondary Outcomes (1)

  • 6 minute walk test

    at the time of session

Study Arms (1)

Observation

Gait quality observation

Diagnostic Test: Camera Based Kinematic Analysis

Interventions

Observational Study using Camera Based, Marker Less Kinematic Analysis of gait quality of persons with Multiple Sclerosis

Also known as: OpenCap
Observation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Persons with multiple sclerosis who can ambulate overground

You may qualify if:

  • Diagnosis of relapsing form of MS (including relapsing-remitting MS and secondary progressive MS)
  • Able to ambulate overground
  • Relapse free for at least 1 month
  • Age ≥18 and ≤ 75 years
  • Participants using dalfampridine will be eligible if taking the same daily dose for at least 2 months prior to screening

You may not qualify if:

  • \- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Chronic ProgressiveMultiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Milap Sandhu, PhD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Share overall data set

Locations