Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders

NCT06774456 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University Hospital, Geneva

Phase

Not applicable

Started

2025-02

Last updated

2025-01-14

Condition(s) studied

Cerebral PalsyBrain InjuryNeurological; Disorder, Nervous System

Investigational drug(s) / intervention(s)

instrumented 3D serious game (BE API 3.0)

instrumented 3D serious game (BE API 3.0): It is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the upper limb (UL) and trunk (3D motion analysis and electromyography), and he/she can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game.

Study summary

The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are:

* Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ?
* Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a "classic" 3D protocol, thanks to the developped environment ?

Researchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement.

Children with neuromotor disorders will have 2 visits to the hospital :

* Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game
* Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game

Typically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.

Eligibility

Sex

ALL

Min age

5 Years

Max age

13 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Children with NMD * Informed Consent signed by the subject * Aged from 5 to 13 years, * Non-progressive neurological lesions (cerebral palsy, stroke, traumatic brain injury, etc.), * With sufficient grasp ability to perform the 3D protocol tasks (MACS level I to III), * TD children * Informed Consent signed by the subject * Aged from 5 to 13 years, Exclusion Criteria: * Children with neuromotor disorders * inability to follow the procedures of the investigation because of severe cognitive or visual disturbances, * upper limb (UL) disorders that may affect movement (fractures less than 6 months prior to participation, pain (visual analogic score (VAS) score \> 0), etc.). * previous UL surgery, and botulinum toxin injections less than three months prior to participation, * TD children * Inability to follow the procedures of the investigation because of severe visual disturbances, * UL disorders that may affect movement (fractures less than 6 months prior to participation, pain (VAS score \> 0), etc.).

Primary outcome measure(s)

Arm Profile Score — Baseline and 2 weeks after
A kinematic index (upper limb movement feature) which reflects the severity of the deviations of the subject's movement compared with a group of typically developing children. The measure ranges from 0° to infinity. The measure is expressed in degrees. The higher the measure, the more abnormal the deviation is.

Trial sites (1)

Facility	City	Region	Status
Geneva University Hospital	Geneva	Switzerland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774456 on ClinicalTrials.gov ↗ ← All trials in Switzerland