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Recruiting NCT06866730

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

No phase Interventional Neurologic Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serious game.
Who it may be relevant to
Registry conditions: Neurologic Disorder. Basic parameters: 4 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Intensive Repetitive Motor Training in Toy Manipulation Supported by Gamified Physical Training Software in Children and Adolescents with Neurological Disorders Impacting Motor Skills

Overview

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).

Interventions

  • Device Serious game
    Serious game in which participants manipulate instrumented toys

Primary outcome measures

  • Box and Blocks test [Time frame: 3 months]
Secondary outcome measures (2)
  • Active Range of Motion [Time frame: 3 months]
  • Assisting Hand Assessment [Time frame: 3 months]

Eligibility criteria

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 in the study.

Exclusion criteria

  • A diagnosis of photosensitive epilepsy mentioned in the medical record AND/OR a note in the child's medical record or reported by the parents of a history of seizures triggered by video game use.
  • Botulinum toxin treatment within the 3 months prior to the study or intensive rehabilitation of manual skills (e.g., mCIMT, HABIT, etc.).
  • Sensory and/or cognitive impairments that would interfere with playing the game.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 2 centers
  • CRMTP Elisatbeth de la Panouse-Debré — Antony
  • Fondation Ellen Poidatz — Saint-Fargeau-Ponthierry

Identifiers

NCT: NCT06866730 · REPLAY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗