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

Официальное название

Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.).

Первичные конечные точки

• Arm Profile Score [Срок оценки: Baseline and 2 weeks after]

Вторичные конечные точки (12)

• Kinematics [Срок оценки: Baseline and 2 weeks after]
• Movement quality - smoothness [Срок оценки: Baseline and 2 weeks after]
• Movement quality - trajectory [Срок оценки: Baseline and 2 weeks after]
• Spatiotemporal - velocity [Срок оценки: Baseline and 2 weeks after]
• Spatiotemporal - duration [Срок оценки: Baseline and 2 weeks after]
• Electromyography [Срок оценки: Baseline and 2 weeks after]
• Muscle strength [Срок оценки: 1 day]
• Muscle spasticity [Срок оценки: 1 day]
• Muscle selectivity [Срок оценки: 1 day]
• Melbourne Assessment Test [Срок оценки: 1 day]
• Assisting Hand Assessment (AHA) [Срок оценки: 1 day]
• Abilhand-Kids [Срок оценки: 1 day]

Критерии участия

Критерии включения

• 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,

Критерии исключения

• 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.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швейцария · 1 центр

• Geneva University Hospital — Geneva

Публикации

• 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

Идентификаторы

NCT: NCT06774456 · 2024-02423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗