Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06866730

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Neurologic Disorder Nervous System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CRMTP Elisatbeth de la Panouse-Debré, Antony, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serious Game

Device

Serious game in which participants manipulate instrumented toys

Primary outcomes

  1. Box and Blocks test

    Time frame: 3 months

    Participant must transfer, one by one, with one hand, a maximum number of cubes from one side to the other of the box in 1 minute. A higher score represents better performance.

Secondary outcomes

  1. Active Range of Motion

    Time frame: 3 months

    Measurement of the angle of active wrist extension and supination.

  2. Assisting Hand Assessment

    Time frame: 3 months

    Determine a score of natural use of the affected upper limb in standardized activity test. The Assisting Hand Assessment contains 20 items rated on a 4-point scale (4=effective, 3=somewhat effective, 2=ineffective, and 1=does not do). A higher score therefore represents better performance.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Desailly, Ph.D.

CONTACT

[email protected]

+33 1 60 65 27 65

Sponsors and collaborators

Lead sponsor

Fondation Ellen Poidatz

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.