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

NCT06774456 | Not Yet Recruiting

• 1 other identifier: 2024-02423
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Brain Injury; Neurological; Disorder, Nervous System

Keywords

Children; upper limb; motion analysis; serious game; neuromotor disorders; bimanual function; electromyography

Outcome Measures

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.

  Baseline and 2 weeks after

Secondary Outcomes (15)

• Kinematics

  Baseline and 2 weeks after

• 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

Study Arms (2)

Children with neuromotor disorders

OTHER

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.

Device: instrumented 3D serious game (BE API 3.0)

Typically developing children

OTHER

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.

Device: instrumented 3D serious game (BE API 3.0)

Interventions

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.

Also known as: Clinical and functional tests, Validated 3D protocol (old version), Questionnaires

Children with neuromotor disorders; Typically developing children

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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,

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, 1205, Switzerland

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Neurologic Manifestations

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Marine Cacioppo, MD, PhD

CONTACT

+41 79 553 84 67; marine.cacioppo@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

CH (1)