Clinical trial NCT06774456: Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
Official title: Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Brain Injury
Neurological; Disorder, Nervous System
Keywords: Children
upper limb
motion analysis
serious game
neuromotor disorders
bimanual function
electromyography
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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 outcomes:
measure: Arm Profile Score
timeFrame: Baseline and 2 weeks after
Secondary outcomes:
measure: Kinematics
timeFrame: Baseline and 2 weeks after
measure: Movement quality - smoothness
timeFrame: Baseline and 2 weeks after
measure: Movement quality - trajectory
timeFrame: Baseline and 2 weeks after
measure: Spatiotemporal - velocity
timeFrame: Baseline and 2 weeks after
measure: Spatiotemporal - duration
timeFrame: Baseline and 2 weeks after
measure: Electromyography
timeFrame: Baseline and 2 weeks after
measure: Muscle strength
timeFrame: 1 day
measure: Muscle spasticity
timeFrame: 1 day
measure: Muscle selectivity
timeFrame: 1 day
measure: Melbourne Assessment Test
timeFrame: 1 day
measure: Assisting Hand Assessment (AHA)
timeFrame: 1 day
measure: Abilhand-Kids
timeFrame: 1 day
measure: Short Feedback Questionnaire
timeFrame: 1 day
measure: User Satisfaction Evaluation Questionnaire
timeFrame: 1 day
measure: System Usability Scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospital
Study officials:
References:
citation: Cacioppo M, Loos A, Lempereur M, Brochard S. Bimanual movements in children with cerebral palsy: a systematic review of instrumented assessments. J Neuroeng Rehabil. 2023 Feb 27;20(1):26. doi: 10.1186/s12984-023-01150-7.
citation: Gaillard F, Cacioppo M, Bouvier B, Bouzille G, Newman CJ, Pasquet T, Cretual A, Rauscent H, Bonan I. Assessment of bimanual performance in 3-D movement analysis: Validation of a new clinical protocol in children with unilateral cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):408-415. doi: 10.1016/j.rehab.2019.06.008. Epub 2019 Jul 10.
citation: Cacioppo M, Lempereur M, Houx L, Bouvier S, Bailly R, Brochard S. Detecting Movement Changes in Children with Hemiparesis after Upper Limb Therapies: A Responsiveness Analysis of a 3D Bimanual Protocol. Sensors (Basel). 2023 Apr 24;23(9):4235. doi: 10.3390/s23094235.
citation: Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.