Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: instrumented 3D serious game (BE API 3.0).
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, Brain Injury, Neurological; Disorder, Nervous System. Basic parameters: 5 years — 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
Overview
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.
Interventions
- Device 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.).
Primary outcome measures
- Arm Profile Score [Time frame: Baseline and 2 weeks after]
Secondary outcome measures (12)
- Kinematics [Time frame: Baseline and 2 weeks after]
- Movement quality - smoothness [Time frame: Baseline and 2 weeks after]
- Movement quality - trajectory [Time frame: Baseline and 2 weeks after]
- Spatiotemporal - velocity [Time frame: Baseline and 2 weeks after]
- Spatiotemporal - duration [Time frame: Baseline and 2 weeks after]
- Electromyography [Time frame: Baseline and 2 weeks after]
- Muscle strength [Time frame: 1 day]
- Muscle spasticity [Time frame: 1 day]
- Muscle selectivity [Time frame: 1 day]
- Melbourne Assessment Test [Time frame: 1 day]
- Assisting Hand Assessment (AHA) [Time frame: 1 day]
- Abilhand-Kids [Time frame: 1 day]
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- Geneva University Hospital — Geneva
Publications
- 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. PMID 36849971
- 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. PMID 31301386
- 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. PMID 37177439
- 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. PMID 33091791
Identifiers
NCT: NCT06774456 · 2024-02423