Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arm Profile Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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,
排除标准
- •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.).
研究组 & 干预措施
Children with neuromotor disorders
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.
干预措施: instrumented 3D serious game (BE API 3.0) (Device)
Typically developing children
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.
干预措施: instrumented 3D serious game (BE API 3.0) (Device)
结局指标
主要结局
Arm Profile Score
时间窗: Baseline and 2 weeks after
A kinematic index (upper limb movement feature) which reflects the severity of the deviations of the subject's movement compared with a group of typically developing children. The measure ranges from 0° to infinity. The measure is expressed in degrees. The higher the measure, the more abnormal the deviation is.
次要结局
- Movement quality - smoothness(Baseline and 2 weeks after)
- Movement quality - trajectory(Baseline and 2 weeks after)
- Spatiotemporal - velocity(Baseline and 2 weeks after)
- Spatiotemporal - duration(Baseline and 2 weeks after)
- Electromyography(Baseline and 2 weeks after)
- Kinematics(Baseline and 2 weeks after)
- Muscle strength(1 day)
- Muscle spasticity(1 day)
- Muscle selectivity(1 day)
- Melbourne Assessment Test(1 day)
- Assisting Hand Assessment (AHA)(1 day)
- Abilhand-Kids(1 day)
- Short Feedback Questionnaire(1 day)
- User Satisfaction Evaluation Questionnaire(1 day)
- System Usability Scale(1 day)
研究者
Marine Cacioppo
MD, PhD
University Hospital, Geneva