Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders (Play2BEAPI)

University Hospitals (UH)

Status: Not yet enrolling

Conditions: Neurological; Disorder, Nervous System; Brain Injury; Cerebral Palsy

Treatments: Device: instrumented 3D serious game (BE API 3.0)

Study type: Interventional

Funder types: Other

Identifiers

NCT06774456

2024-02423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 5 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Children with neuromotor disorders

Other group

Description:

During Visit 1, children will perform both a validated 3D protocol and the instrumented 3D serious game (developed version). After each session, questionnaires will be distributed to participants to assess the added value of the immersive environment. During Visit 2, children will have a clinical examination (goniometry, muscle strength, spasticity, motor selectivity) and functional assessments by experienced therapists at hospital and will perform the instrumented 3D serious game.

Treatment:

Device: instrumented 3D serious game (BE API 3.0)

Typically developing children

Other group

Description:

Children will have one visit to the hospital (Visit 1). They will perform the instrumented serious game, in order to assess the discriminant validity of the upper limb movement features between children with neuromotor disorders and typically developing children.

Treatment:

Device: instrumented 3D serious game (BE API 3.0)