Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06866730 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2025 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Interventions: Serious game (Other) to Serious game (Device)
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06866730
Lead Sponsor Fondation Ellen Poidatz
Conditions
(from sponsor)
Neurologic Disorder
Related terms Nervous System Diseases
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov