- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07491588
Context- and Terrain-aware Gait Analysis (CTAGA)
Context- and Terrain-aware Gait Analysis and Visualisation
The average lifespan of individuals in many developed countries is increasing. This factor paired with the increase in global population has the potential to put a strain on healthcare systems with regards to age-related conditions. Particularly, this research considers the impact that conditions such as Parkinson's disease, dementia and stroke have on the walking capabilities on affected individuals.
This research project aims to obtain a gait analysis dataset consisting of sensor data captured during regular daily activities on common terrains such as grass, paving slabs, gravel, etc. The dataset will be collected with a custom sensor system which captures mobility data from a cohort of healthy controls of all ages and people with dementia, Parkinson's disease, stroke survivors, multiple sclerosis, etc. Various machine learning algorithms (custom-implemented using Python) will then be used to determine the walking activity (walking, ramp ascend/descend, stair ascend/descend etc.), the terrain (grass, pavement, carpet etc.), and various walking-related parameters (step length, step height, cadence etc.). It is our hope that these features will enable remote gait analysis to be performed with sufficient contextual information to enable remote diagnosis and rehabilitation tracking for those at risk of falling.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Walking is a crucial ability to allow people to live normal, healthy lives. However, various conditions which affect the brain or the body such as Parkinson's disease, dementia, stroke, multiple sclerosis, and amputations threaten a person's ability to walk and can lead to falls or the fear of falling. Either of these fall-related burdens can severely affect the quality of life for a person, particularly those who are most vulnerable, such as older people.
To detect fall-related issues in a person's manner of walking (their gait), a process called gait-analysis can be performed which involves a team of specialists using video cameras to record someone walking in a laboratory environment and analyse the video to identify problems. However, current technology is rapidly advancing towards the capacity for remote gait analysis, which uses wearable sensor technologies to capture one's gait. This provides many benefits such as a more natural walking style, automatic data analysis, and reduced time needed by specialists to perform the analysis. The largest of these benefits, however, is the capacity to wear the device outside of the laboratory to see how a person walks on real terrains.
Many current studies have shown great strides in producing highly accurate gait analysis systems. However, a real-environment dataset for these systems to be tested on does not yet exist. Furthermore, datasets including a range of people with conditions that increase their risk of falling are scarce and typically only focus on one group. This study aims to produce and analyse the first real-world gait analysis dataset which includes a wide range of gait-affecting conditions, and to highlight what worked and what didn't for future researchers to build off when designing and implementing practical solutions to real-environment gait analysis.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Confirmed diagnosis of Parkinson's disease, dementia, acquired brain injury (stroke, cerebral palsy, etc.), multiple sclerosis, or have had a lower limb amputation.
- Under the care of a Leeds consultant or specialist nurse
- Able to walk indoors and outdoors without a walking aid
Exclusion Criteria:
- Age < 18 years
- Skin condition on feet, ankles, or waist that prevents wearing the sensor system.
- Cognitive impairment causing inability to consent.
- Unable to walk safely with provided shoes (need for specialist shoes).
- Allergy to silicone or elastic fibres
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Gait analysis
Group whose gait is being analysed
|
Mobile gait analysis system for environmental gait analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants to complete gait analysis using the All-terrain Gait Analysis System
Time Frame: From enrollment to the completion of the gait analysis.
|
The number of participants who are able to complete all elements of the All-terrain Gait Analysis System, which is a mobile gait analysis system to analyse gait in the environment, will be recorded to assess the feasibility of using the system in a larger observational study.
|
From enrollment to the completion of the gait analysis.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rory J O'Connor, MD, University of Leeds
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Autoimmune Diseases
- Immune System Diseases
- Neurocognitive Disorders
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neurodegenerative Diseases
- Movement Disorders
- Craniocerebral Trauma
- Trauma, Nervous System
- Basal Ganglia Diseases
- Multiple Sclerosis
- Wounds and Injuries
- Brain Injuries
- Parkinson Disease
- Dementia
- Parkinsonian Disorders
Other Study ID Numbers
- 306353
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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