Clinical trial NCT06866730: Effect of Using an Object Handling Serious Game on Upper Limb Rehabilitation for Children with Neurological Disorders
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurologic Disorder
Lead sponsor: Fondation Ellen Poidatz
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Box and Blocks test
timeFrame: 3 months
Secondary outcomes:
measure: Active Range of Motion
timeFrame: 3 months
measure: Assisting Hand Assessment
timeFrame: 3 months
Other outcomes:
Locations:
city: Antony
country: France
facility: CRMTP Elisatbeth de la Panouse-Debré
city: Saint-Fargeau-Ponthierry
country: France
facility: Fondation Ellen Poidatz
Study officials:
References: