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

NCT ID: NCT06866730

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Neurologic Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Case Experimental Design
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serious game upper limb rehabilitation

4 weeks program with 3 sessions per week of 40 minutes of serious game to improve upper limp motor function

Group Type EXPERIMENTAL

Serious game

Intervention Type DEVICE

Serious game in which participants manipulate instrumented toys

Interventions

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Serious game

Serious game in which participants manipulate instrumented toys

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ellen Poidatz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CRMTP Elisatbeth de la Panouse-Debré

Antony, , France

Site Status RECRUITING

Fondation Ellen Poidatz

Saint-Fargeau-Ponthierry, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric Desailly, Ph.D.

Role: CONTACT

+33 1 60 65 27 65

Facility Contacts

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Eric Desailly, Ph.D.

Role: primary

+33 1 60 65 27 65

Eric Desailly, Ph.D.

Role: primary

+33 1 60 65 27 65

Other Identifiers

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REPLAY

Identifier Type: -

Identifier Source: org_study_id

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