Cerebral PalsyNCT04837105
Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy
A study testing Serious game ARROW CP and Treadmill in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Fondation Ellen Poidatz at 1 site in France.
Trial summary
Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cerebral Palsy, Gait Disorders, Neurologic
- What is being tested?
- Serious game ARROW CP and Treadmill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2021to 31 Dec 2025
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A clinical diagnosis of CP mentioned in the medical record
- Minor child for the entire duration of the protocol, i.e. between 10 and 17 years of age (the child must be less than 18 years of age at the time of the last check-up scheduled 1 year after inclusion in the study)
- Global Motor Function Classification System (GMFCS) levels I to III
- Functional Mobility Scale 50 meters rating superior or equal to 2 (ability to walk on 50m using a walker or frame without help from another person)
- Ability to cooperate, understand and follow simple instructions to play.
- Patient affiliated to the French social security system
- Voluntary patient whose parents have given their consent for their child to participate in the study
- Patient who has undergone multisite surgery of the lower limbs including bone procedures at least 7 weeks before the start of the procedure
Who cannot join
- A diagnosis of photosensitive epilepsy mentioned in the medical file AND/OR a mention in the child's medical file or by the parents or by the child of a history of epileptic seizures occurring during the practice of a video game
- A visual, cognitive or auditory impairment at a level that would interfere with playing the game. The patient must have normal or corrected vision and hearing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, Île-de-France Region, 77310
Eric Desailly, PhD, 160652765 ext. +33, eric.desailly@fondationpoidatz.com
About this study
Official title: Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial
Cerebral palsy (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery.
The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.
Read the detailed description
This study is a randomized control trial.
Participants are children with cerebral palsy having a single event multi level surgery. They are involving in a rehabilitation protocol in the same rehab center.
Two groups are formed:
- control group: classic rehab+children have treadmill gait protocol during 4 weeks
- test group : classic rehab+children have gait training with the ARROW CP serious game.
ARROW CP game is developed for augmented reality headset (Microsoft Hololens). It delivers feedback in real time and with delay on participant gait performance. This game has been developed by researchers (Fondation Ellen Poidatz, France).
The aims of this study are:
- . To determine the impact on spatiotemporal gait parameters of intensive gait rehabilitation involving the use of a serious AR game in children and adolescents with cerebral palsy.
- To explore the effects of playing a serious game on functional abilities
- To assess motivation, satisfaction and adherence to treatment
- Conditions
- Cerebral Palsy, Gait Disorders, Neurologic
- Being tested
- Serious game ARROW CP, Treadmill
- Keywords
- physiotherapy, gait rehabilitation, serious game, multi level surgery
- Medical subject headings
- Cerebral Palsy, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious game ARROW CPOther
ARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during "sprint session".
TreadmillOther
Participant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Classic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3*/week/4weeks:
5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed.
(protocol from Grecco et al.) Receives: Other: Treadmill |
| Test group | Experimental | Classic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3*/week/4weeks:
walking sprint session at maximal speed with gradual increase in number of repetitions over the weeks.
(protocol from Verschuren et al.) Receives: Other: Serious game ARROW CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test
Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length).
Procedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
Measured: 6 minutes
Secondary outcomes (3)
Muscle power sprint test
Aim of the measurement: To assess the anaerobic capacity of children with motor disabilities.
Procedure: The patient is asked to perform six 15-metre walking sprints, with 10 seconds of rest between each sprint. The average and maximum power are calculated based on the speeds achieved during the sprints.
Measured: 10 minutes
Shuttle run test I and II (adapted for children with CP)
In this test, the child must walk between 2 poles spaced 10 metres apart following the "beep rhythm" imposed by a pre-recorded soundtrack. The soundtrack includes an increase in walking speed of 0.25 km/h every minute.
(Verschuren et al.)
Measured: 20 minutes
Questionnaire (PACES)
To assess enjoyment for both control and test group, the 16-items of the Physical Activity Enjoyment Scale (PACES) will be used. The PACES is a valid and re- liable measure of physical activity enjoyment. It has been used in many studies assessing the effectiveness of VR therapy This questionnaire will be presented to the participant at the end of the last session.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial - 2 groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 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
- NCT04837105
- Sponsor's protocol ID
- ARROW CP
- Status last verified
- Aug 2025
- First submitted
- 6 Apr 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guinet AL, Bams M, Payan-Terral S, Khouri N, Otmane S, Bouyer G, Desailly E. Effect of an augmented reality active video game for gait training in children with cerebral palsy following single-event multilevel surgery: protocol for a randomised controlled trial. BMJ Open. 2022 Oct 10;12(10):e061580. doi: 10.1136/bmjopen-2022-061580.
PubMed 36216413
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Game-based Intervention in Gait Rehabilitation for Children With Cerebral Palsy: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04837105
- Acronym / sponsor ID
- ARROW CP
- Conditions
- Cerebral Palsy, Gait Disorders, Neurologic
- Keywords
- physiotherapy, gait rehabilitation, serious game, multi level surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Fondation Ellen PoidatzUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Apr 2021 (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 (CP) is defined as a group of movement and posture disorders that cause activity limitation due to brain damage during fetal development or in the first year of life. Motor activities, and in particular walking, can be affected by many factors including sensory deficits, biomechanical and postural limitations, muscle weakness and spasticity. Theories of gait training guide rehabilitation management strategies. Among these, intensification, variability and specific training of walking parameters (speed, step length, cadence) have shown their effectiveness. Delivering sensory feedback during gait rehabilitation exercises is a complementary approach to improve motor learning during rehabilitation. On the other hand, motivation is a key factor in the success of rehabilitation. The addition of walking exercises performed through a serious game in augmented reality (AR) appears relevant for the rehabilitation of children with CP after surgery.
The serious game ARRoW-CP is based on the latest advances in the literature in terms of gait rehabilitation protocol but also on the results of a clinical study conducted by our team, to identify the best feedback modalities to be delivered during the serious rehabilitation game.
Detailed description
This study is a randomized control trial.
Participants are children with cerebral palsy having a single event multi level surgery. They are involving in a rehabilitation protocol in the same rehab center.
Two groups are formed:
- control group: classic rehab+children have treadmill gait protocol during 4 weeks
- test group : classic rehab+children have gait training with the ARROW CP serious game.
ARROW CP game is developed for augmented reality headset (Microsoft Hololens). It delivers feedback in real time and with delay on participant gait performance. This game has been developed by researchers (Fondation Ellen Poidatz, France).
The aims of this study are:
- . To determine the impact on spatiotemporal gait parameters of intensive gait rehabilitation involving the use of a serious AR game in children and adolescents with cerebral palsy.
- To explore the effects of playing a serious game on functional abilities
- To assess motivation, satisfaction and adherence to treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized control trial - 2 groups
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: TreadmillClassic rehab (physio including strength rehab, fitness, motor activity...) + treadmill gait training 3*/week/4weeks: 5 minutes of warm-up with gradual increase in treadmill speed, max 20 minutes of walking at 80% of maximum speed, 5 minutes of active recovery with gradual decrease in treadmill speed. (protocol from Grecco et al.) |
| Test group | Experimental | Other: Serious game ARROW CPClassic rehab - same as control group - (physio including strength rehab, fitness, motor activity...) + overground ARROW CP gait training 3*/week/4weeks: walking sprint session at maximal speed with gradual increase in number of repetitions over the weeks. (protocol from Verschuren et al.) |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- A clinical diagnosis of CP mentioned in the medical record
- Minor child for the entire duration of the protocol, i.e. between 10 and 17 years of age (the child must be less than 18 years of age at the time of the last check-up scheduled 1 year after inclusion in the study)
- Global Motor Function Classification System (GMFCS) levels I to III
- Functional Mobility Scale 50 meters rating superior or equal to 2 (ability to walk on 50m using a walker or frame without help from another person)
- Ability to cooperate, understand and follow simple instructions to play.
Key exclusion criteria (2 listed)
- A diagnosis of photosensitive epilepsy mentioned in the medical file AND/OR a mention in the child's medical file or by the parents or by the child of a history of epileptic seizures occurring during the practice of a video game
- A visual, cognitive or auditory impairment at a level that would interfere with playing the game. The patient must have normal or corrected vision and hearing.
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 game ARROW CPARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during "sprint session". | Other | Test group |
| TreadmillParticipant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes (+5 min warm-up / 5 min cool-down) | Other | Control group |
Primary outcome
6 minutes walking test
Time frame: 6 minutes
Aim of the measurement: To quantify changes in the parameters of walking quality (speed, cadence, step length). Procedure: The patient is instructed to walk for 6 minutes in an unobstructed corridor. The distance walked is recorded for the calculation of walking speed. Fatigue is assessed with a Borg scale and heart rate is continuously recorded.
3 secondary outcomes
Muscle power sprint test
Time frame: 10 minutes
Shuttle run test I and II (adapted for children with CP)
Time frame: 20 minutes
Questionnaire (PACES)
Time frame: 10 minutes
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 24 Aug 2025.
- Derived from this study: PubMed 36216413Guinet AL, Bams M, Payan-Terral S, Khouri N, Otmane S, Bouyer G, Desailly E. Effect of an augmented reality active video game for gait training in children with cerebral palsy following single-event multilevel surgery: protocol for a randomised controlled trial. BMJ Open. 2022 Oct 10;12(10):e061580. doi: 10.1136/bmjopen-2022-061580.
- Fondation Ellen Poidatz ARROW CPLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Fondation Ellen Poidatz
Saint-Fargeau-Ponthierry, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game ARROW CP and Treadmill in people with Cerebral Palsy and Gait Disorders, Neurologic, run by Fondation Ellen Poidatz at 1 site 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 8 inclusion and 2 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 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04837105, which also lists 1 linked publication.
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 24 Aug 2025.