Effect of Using an Object Handling Serious Game on Upper Limb Rehabilitation for Children with Neurological Disorders

Last updated: March 11, 2025
Sponsor: Fondation Ellen Poidatz
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Treatment

Serious game

Serious game

Clinical Study ID

NCT06866730
REPLAY
  • Ages 4-17
  • All Genders

Study Summary

Cerebral palsy, and more broadly neurological disorders, can lead to significant motor impairments that impact individuals' daily lives. To address these limitations, the French National Authority for Health has issued recommendations for rehabilitative care, highlighting intensive training programs, physical activity, and interactive computer games. Scientific literature has also demonstrated the benefits of therapies that incorporate repetition.

In this study, the investigators aimed to train patients in producing grasp-and-release movements, and more broadly reach-to-grasp actions, in a manner intensified by movement repetition. To mitigate the boredom inherent to such repetitive tasks, the invesigators developed a device resembling a serious game, equipped with software, a modular physical platform, and two instrumented figurines designed to interact with the software.

Intensive therapy through repetitive movements, supported by the engaging nature of serious games, is expected to improve the manual skills of children with neurological disorders causing motor impairments.

To test this hypothesis, a cohort of 5 to 10 children aged 4 to 17 years with neurological disorders causing motor impairments will be invited to participate in the protocol. Participants will first undergo a baseline assessment, which will include repeated measurements of their score on the Box and Blocks Test and the active range of motion (AROM) of the wrist in extension and supination. An Assisting Hand Assessment (AHA) test will also be conducted.

Following this, a 4-week intervention will be implemented, consisting of three 40-minute sessions per week. During these sessions, the child will play the game and complete the Box and Blocks Test as well as active range of motion assessments.

In total, approximately 4 hours of gameplay is estimated over the course of the intervention, which will conclude with a repeat of the AHA test.

A follow-up assessment will take place two months after the intervention's end, with a single measurement of the three parameters (Box and Blocks Test, AROM, and AHA).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Neurological disorder causing motor impairment

  • Age 4 to 17 years old

  • MACS level I to III

  • Ability to cooperate, understand, and follow simple instructions to play the game.

  • Patient affiliated with the French social security system.

  • Voluntary patient whose parents have given consent for their child to participate inthe study.

Exclusion

Exclusion Criteria:

  • A diagnosis of photosensitive epilepsy mentioned in the medical record AND/OR a notein the child's medical record or reported by the parents of a history of seizurestriggered by video game use.

  • Botulinum toxin treatment within the 3 months prior to the study or intensiverehabilitation of manual skills (e.g., mCIMT, HABIT, etc.).

  • Sensory and/or cognitive impairments that would interfere with playing the game.

Study Design

Total Participants: 10
Treatment Group(s): 2
Primary Treatment: Serious game
Phase:
Study Start date:
November 12, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • CRMTP Elisatbeth de la Panouse-Debré

    Antony, 92160
    France

    Active - Recruiting

  • Fondation Ellen Poidatz

    Saint-Fargeau-Ponthierry, 77310
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.