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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06774456
• Lead Sponsor: University Hospital, Geneva

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Study Start: 2025-02
• Primary Completion: 2026-09
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Arm Profile Score	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.

Secondary Outcome Measures

Name	Time	Method
Kinematics	Baseline and 2 weeks after	Joint angular values, in degrees
Movement quality - smoothness	Baseline and 2 weeks after	A movement features obtained with 3D motion analysis (spectral arc length). No unit
Movement quality - trajectory	Baseline and 2 weeks after	A movement features obtained with 3D motion analysis (index of curvature), in degrees
Spatiotemporal - velocity	Baseline and 2 weeks after	A movement features obtained with 3D motion analysis. Velocity, in meter/seconds
Spatiotemporal - duration	Baseline and 2 weeks after	A movement features obtained with 3D motion analysis. Duration in seconds
Electromyography	Baseline and 2 weeks after	muscle activity in microVolt
Muscle strength	1 day	Muscle strength will be evaluated using the Medical Research Council scale (Paternostro-Sluga et al., 2008), a six-point ordinal scale from 0 to 5 in which 0 indicates no muscle contraction and 5 indicates normal strength. A composite strength score will be defined as the sum of the muscle weakness scores (total score: 0-80).
Muscle spasticity	1 day	Muscle spasticity will be evaluated with the Modified Ashworth Scale (MAS) (Mutlu et al., 2008), a six-point ordinal scale, rating from 0 to 4 (possible scores: 0,1,1+,2,3,4). A score of 0 represents normal muscle tone, whereas a score of 4 corresponds to no possible movement due to rigidity. A composite spasticity score, rated from 0 to 5, will be defined as the sum of MAS scores for each child (total score: 0-80 \[16 muscles × 5 levels\]).
Muscle selectivity	1 day	Muscle selectivity was evaluated using selective motor control (SMC) (Masson, n.d.), a five-point ordinal scale from 0 to 2, in increments of 0.5, in which a score of 2 corresponded to normal selectivity. A composite selectivity score was defined as the sum of the muscle selectivity scores (total score: 0-32).
Melbourne Assessment Test	1 day	It is a valid and reliable criterion-referenced test of impaired upper limb movement quality. The final score is reported as 4 separate sub-scores, 1 for each item of movement quality, reported on a scale from 0-100%, where 100% corresponds to full functional capacity.
Assisting Hand Assessment (AHA)	1 day	It is video recorded and rated using video-based scoring. It involves the evaluation of 22 bimanual activities. The total score ranges from 0 to 100 AHA-units; 100 AHA-units indicates normal spontaneous use of the impaired hand.
Abilhand-Kids	1 day	It is a questionnaire of bimanual daily life activities addressed to parents. Parents are asked to rate their child's difficulty on a 3-level scale (range from 0 to 2) for 21 items. The manual ability scale is calibrated in logits (i.e., log-odds units).
Short Feedback Questionnaire	1 day	It is a short post-immersive and presence questionnaire containing only six questions. Each item is rated from 0 to 5 (1 = not at all ; 5 = very much)
User Satisfaction Evaluation Questionnaire	1 day	It is a questionnaire developed in order to evaluate user satisfaction with rehabilitation systems. It comprises six questions that can be rated on a Likert scale ranging from 1 (not at all) to 5 (very much).
System Usability Scale	1 day	It is a questionnaire of usability. It is composed of 10 items. Only for the purpose of this study, the word "interface" in the items has been used interchangeably with the word "game". Each item's score ranged from 0 to 4. For items 1, 3, 5, 7 and 9 (odd-numbered items) the score contribution was the scale position minus 1. For items 2, 4, 6, 8 and 10 (even-numbered items) the score contribution was 5 minus the scale position. Next, we multiplied the sum of scores by 2.5 to obtain the overall System Usability value. SUS scores range from 0 to 100.

Trial Locations

Locations (1)

Geneva University Hospital; 🇨🇭 Geneva, Switzerland