Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2025-12-30 @ 8:24 PM
Study NCT ID:
NCT06774456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Play2BEAPI
Brief 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.
* 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.
Detailed Description:
The instrumented 3D serious game (BE API 3.0) will be performed during a 3D motion analysis session. It is composed of:
* One screen (35 pouces)
* Game set up (2-handed joystick, turbo, shifter, dashboard, box, coins and buzzer) instrumented with sensors to link the game and measure grasp strength.
* Software: Unity software (version 2022.3.21f1, Unity Technologies, San Francisco, California, USA)
The game is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the UL and trunk, 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.
* One screen (35 pouces)
* Game set up (2-handed joystick, turbo, shifter, dashboard, box, coins and buzzer) instrumented with sensors to link the game and measure grasp strength.
* Software: Unity software (version 2022.3.21f1, Unity Technologies, San Francisco, California, USA)
The game is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the UL and trunk, 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: