Neurologic DisorderNCT06866730
Effect of Using an Object Handling Serious Game on Upper Limb Rehabilitation for Children with Neurological Disorders
A study testing Serious game in people with Neurologic Disorder, run by Fondation Ellen Poidatz at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Serious game
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Nov 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CRMTP Elisatbeth de la Panouse-Debré
Antony, 92160
Eric Desailly, Ph.D., +33 1 60 65 27 65, eric.desailly@fondationpoidatz.com
- Recruiting
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, 77310
Eric Desailly, Ph.D., +33 1 60 65 27 65, eric.desailly@fondationpoidatz.com
About this study
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
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.
Read more
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).
- Conditions
- Neurologic Disorder
- Being tested
- Serious game
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gameDevice
Serious game in which participants manipulate instrumented toys
| Study group | Role | What they receive |
|---|---|---|
| Serious game upper limb rehabilitation | Experimental | 4 weeks program with 3 sessions per week of 40 minutes of serious game to improve upper limp motor function Receives: Device: Serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks test
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.
Measured: 3 months
Secondary outcomes (2)
Active Range of Motion
Measurement of the angle of active wrist extension and supination.
Measured: 3 months
Assisting Hand Assessment
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start12 Nov 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ellen Poidatz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866730
- Sponsor's protocol ID
- REPLAY
- Status last verified
- Mar 2025
- First submitted
- 18 Nov 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06866730
- Acronym / sponsor ID
- REPLAY
- Conditions
- Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondation Ellen PoidatzUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design
| Arm | Type | Receives |
|---|---|---|
| Serious game upper limb rehabilitation | Experimental | Device: Serious game4 weeks program with 3 sessions per week of 40 minutes of serious game to improve upper limp motor function |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serious gameSerious game in which participants manipulate instrumented toys | Device | Serious game upper limb rehabilitation |
Primary outcome
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.
2 secondary outcomes
Active Range of Motion
Time frame: 3 months
Assisting Hand Assessment
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game in people with Neurologic Disorder, run by Fondation Ellen Poidatz at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Desailly, Ph.D. (+33 1 60 65 27 65, eric.desailly@fondationpoidatz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Blocks test (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.