Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis (MS-GDI)

Development of Camera Based Gait Deviation Index for Persons With Multiple Sclerosis

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Secondary Progressive; Multiple Sclerosis Relapse
• Intervention / Treatment: Diagnostic test: Camera Based Kinematic Analysis

Detailed Description

In rehabilitation in general, in order to track patients' progress and provide next steps, there is a need for easily obtainable, understandable, and objective measures of ability. Currently, there is no measure that clinicians can utilize to determine walking quality. While Gait Deviation Index has been validated and can reliably be used in adults who experienced a Spinal Cord Injury, it has not yet been validated in people with MS. After the MS-specific GDI is developed from this study, therapists and clinicians will be able use it as a reliable progress measure. Which may lead to the delivery of more effective therapy for patients with MS.

Here we plan to measure body position with camera based tracking during your gait cycle.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Weena Dee; Phone Number: 312-328-7503; Email: wdee@sralab.org
• Study Contact Backup: Name: Alex Barry; Phone Number: 312-238-1435; Email: abarry@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab
      • Contact: Weena Dee, DPT; Phone Number: 312-238-7503; Email: wdee@sralab.org
      • Contact: Alex Barry, MS,CCRC; Phone Number: 312-238-1435; Email: abarry@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Persons with multiple sclerosis who can ambulate overground

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation; Gait quality observation	Diagnostic test: Camera Based Kinematic Analysis; Observational Study using Camera Based, Marker Less Kinematic Analysis of gait quality of persons with Multiple Sclerosis; Other Names: OpenCap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematics of the gait cycle	Joint position of lower limbs during a single cycle of gait	at the time of session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	you will be instructed to walk as quickly and safely as you can while being timed for 6 minutes	at the time of session

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Milap Sandhu, PhD, Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: STU00221990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Share overall data set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No