Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy (Valid-ABLE)
Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children.
Currently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul ORNETTI
- Phone Number: +33 03.80.29.38.72
- Email: paul.ornetti@chu-dijon.fr
Study Locations
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Dijon, France, 21000
- Recruiting
- CHU Dijon Bourgogne
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Contact:
- Paul ORNETTI
- Phone Number: +33 03.80.29.38.72
- Email: paul.ornetti@chu-dijon.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Common to both groups:
- Obtaining free and informed consent from the child and at least one parent
- Children of all genders aged 6 to 18
- Children affiliated with or beneficiaries of a social security system
For the Cerebral Palsy group:
- Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;
- Unilateral and bilateral impairment;
- Gross Motor Function Classification System (GMFCS) = I to III;
- No major cognitive or visual impairments that limit the performance of motor tasks
For the control group:
- Children free from any disease
Other volunteers included in the protocol (qualitative analysis only (parents and clinicians)):
- Parent(s) of children with CP included in this study;
- Healthcare professionals and researchers involved in monitoring children with CP and/or evaluating the research application within the framework of this study
Exclusion Criteria:
Common to both groups:
- Participants or parent(s) of participants who do not speak French
- Children subject to legal protection measures
- Pregnant or breastfeeding participants
For the Cerebral Palsy group:
- Presence of a cause of neuro-orthopedic disorders other than CP
- Limiting pain
- Surgical procedures performed less than 6 months prior to inclusion in the study
- Any other functional medical intervention that took place 3 months prior to inclusion in the study (e.g., botulinum toxin injections, plaster casts, etc.)
- Medical or surgical interventions planned between visit 1 and visit 2
- Children with a condition other than cerebral palsy that affects their walking ability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Healthy volunteers
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Gold standard
Application
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Experimental: Children with a medical diagnosis of cerebral palsy as defined by SCPE
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Gold standard
ABILOCO-Kids
GOAL
Interview
Application
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software
Time Frame: Up to 8 months
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We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
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Up to 8 months
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Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).
Time Frame: Up to 8 months
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We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
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Up to 8 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
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
Other Study ID Numbers
- GUEUGNON THCS 2024
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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