Multiple SclerosisMS-GDINCT06516458
Development of Camera Based Gait Quality Measure for Persons With Multiple Sclerosis
An observational study of Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis Relapse
- What is being tested?
- Camera Based Kinematic Analysis
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons with multiple sclerosis who can ambulate overground
Who may be able to join
- 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
Who cannot join
- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Weena Dee, DPT, 312-238-7503, wdee@sralab.org
Alex Barry, MS,CCRC, 312-238-1435, abarry@sralab.org
About this study
Official title: 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).
Read the 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.
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis Relapse, Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Camera Based Kinematic Analysis
- Medical subject headings
- Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camera Based Kinematic AnalysisDiagnostic test
Also called OpenCap
Observational Study using Camera Based, Marker Less Kinematic Analysis of gait quality of persons with Multiple Sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Observation | Gait quality observation Receives: Diagnostic Test: Camera Based Kinematic Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics of the gait cycle
Joint position of lower limbs during a single cycle of gait
Measured: at the time of session
Secondary outcomes (1)
6 minute walk test
you will be instructed to walk as quickly and safely as you can while being timed for 6 minutes
Measured: at the time of session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- Milap Sandhu, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516458
- Sponsor's protocol ID
- STU00221990
- Acronym
- MS-GDI
- Status last verified
- Jul 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share overall data set
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Camera Based Gait Deviation Index for Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06516458
- Acronym / sponsor ID
- MS-GDI / STU00221990
- Conditions
- Multiple Sclerosis, Multiple Sclerosis, Secondary Progressive, Multiple Sclerosis Relapse, Multiple Sclerosis, Relapsing-Remitting
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 24 Jul 2024 (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 develop a measurement of walking quality, called Gait Deviation Index (GDI) for people with Multiple Sclerosis (MS).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | Diagnostic Test: Camera Based Kinematic AnalysisGait quality observation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons with multiple sclerosis who can ambulate overground
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Orthopedic injuries, fractures, surgeries or other conditions affecting locomotor function or weight bearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camera Based Kinematic AnalysisAlso: OpenCapObservational Study using Camera Based, Marker Less Kinematic Analysis of gait quality of persons with Multiple Sclerosis | Diagnostic test | Observation |
Primary outcome
Kinematics of the gait cycle
Time frame: at the time of session
Joint position of lower limbs during a single cycle of gait
1 secondary outcome
6 minute walk test
Time frame: at the time of session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No. Share overall data set
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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.
Milap Sandhu, PhD principal investigator
Shirley Ryan AbilityLab
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 Multiple Sclerosis, Secondary Progressive, run by Shirley Ryan AbilityLab 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 5 inclusion and 1 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 24 Jul 2024. 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 Weena Dee (312-328-7503, wdee@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics of the gait cycle (time frame: at the time of session). 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 24 Jul 2024.