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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-13
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.),

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • instrumented 3D serious game (BE API 3.0)

    Device

    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.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Children with neuromotor disordersOther 1 intervention
Group B: Typically developing childrenOther 1 intervention

Trial outcomes

Primary outcomes

1

Arm Profile Score

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.

Time frame
Baseline and 2 weeks after

Secondary outcomes

1

Kinematics

Joint angular values, in degrees

Time frame
Baseline and 2 weeks after
2

Movement quality - smoothness

A movement features obtained with 3D motion analysis (spectral arc length). No unit

Time frame
Baseline and 2 weeks after
3

Movement quality - trajectory

A movement features obtained with 3D motion analysis (index of curvature), in degrees

Time frame
Baseline and 2 weeks after
4

Spatiotemporal - velocity

A movement features obtained with 3D motion analysis. Velocity, in meter/seconds

Time frame
Baseline and 2 weeks after

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: