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: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Assessment of functional abilities; Other: Children's self-questionnaires; Other: Parent self-assessment questionnaires; Other: Semi-structured interview; Other: Assessment of functional abilities

• Study Type: Interventional
• Enrollment (Estimated): 60
• 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

• France
  • Dijon, France, 21000
    • Recruiting
    • Chu Dijon Bourgogne
    • Contact: Paul ORNETTI; Phone Number: +33 03.80.29.38.72; Email: paul.ornetti@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy volunteers	Other: Assessment of functional abilities; Gold standard; Other: Assessment of functional abilities; Application
Experimental: Children with a medical diagnosis of cerebral palsy as defined by SCPE	Other: Assessment of functional abilities; Gold standard; Other: Children's self-questionnaires; ABILOCO-Kids; Other: Parent self-assessment questionnaires; GOAL; Other: Semi-structured interview; Interview; Other: Assessment of functional abilities; Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software	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.	Up to 8 months
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).	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.	Up to 8 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): November 16, 2028
• Study Completion (Estimated): November 16, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: GUEUGNON THCS 2024

Drug and device information, study documents

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