Cerebral PalsyPlay2BEAPINCT06774456
Validation of a 3D Instrumented Serious Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
A study testing instrumented 3D serious game (BE API 3.0) in people with Cerebral Palsy and Brain Injury, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are: Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and… Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Brain Injury, Neurological; Disorder, Nervous System
- What is being tested?
- instrumented 3D serious game (BE API 3.0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2025to Jan 2027
- 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 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with NMD
- Informed Consent signed by the subject
- Aged from 5 to 13 years,
- Non-progressive neurological lesions (cerebral palsy, stroke, traumatic brain injury, etc.),
- With sufficient grasp ability to perform the 3D protocol tasks (MACS level I to III),
- TD children
- Informed Consent signed by the subject
- Aged from 5 to 13 years,
Who cannot join
- Children with neuromotor disorders
- inability to follow the procedures of the investigation because of severe cognitive or visual disturbances,
- upper limb (UL) disorders that may affect movement (fractures less than 6 months prior to participation, pain (visual analogic score (VAS) score > 0), etc.).
- previous UL surgery, and botulinum toxin injections less than three months prior to participation,
- TD children
- Inability to follow the procedures of the investigation because of severe visual disturbances,
- UL disorders that may affect movement (fractures less than 6 months prior to participation, pain (VAS score > 0), etc.).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Geneva University Hospital
Geneva, 1205
Elodie Von Dach, PhD, +41223729827, Elodie.vonDach@hug.ch
About this study
Official title: Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are:
- Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ?
- Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a "classic" 3D protocol, thanks to the developped environment ?
Read more
Researchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement.
Children with neuromotor disorders will have 2 visits to the hospital :
- Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game
- Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game
Typically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.
Read the detailed description
The instrumented 3D serious game (BE API 3.0) will be performed during a 3D motion analysis session. It is composed of:
- One screen (35 pouces)
- Game set up (2-handed joystick, turbo, shifter, dashboard, box, coins and buzzer) instrumented with sensors to link the game and measure grasp strength.
- Software: Unity software (version 2022.3.21f1, Unity Technologies, San Francisco, California, USA)
The game is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the UL and trunk, and he/she can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game.
- Being tested
- instrumented 3D serious game (BE API 3.0)
- Keywords
- Children, upper limb, motion analysis, serious game, neuromotor disorders, bimanual function, electromyography
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrumented 3D serious game (BE API 3.0)Device
Also called Clinical and functional tests, Validated 3D protocol (old version), Questionnaires
It is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the upper limb (UL) and trunk (3D motion analysis and electromyography), and he/she can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game.
| Study group | Role | What they receive |
|---|---|---|
| Children with neuromotor disorders | Other | During Visit 1, children will perform both a validated 3D protocol and the instrumented 3D serious game (developed version). After each session, questionnaires will be distributed to participants to assess the added value of the immersive environment.
During Visit 2, children will have a clinical examination (goniometry, muscle strength, spasticity, motor selectivity) and functional assessments by experienced therapists at hospital and will perform the instrumented 3D serious game. Receives: Device: instrumented 3D serious game (BE API 3.0) |
| Typically developing children | Other | Children will have one visit to the hospital (Visit 1). They will perform the instrumented serious game, in order to assess the discriminant validity of the upper limb movement features between children with neuromotor disorders and typically developing children. Receives: Device: instrumented 3D serious game (BE API 3.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Profile Score
A kinematic index (upper limb movement feature) which reflects the severity of the deviations of the subject's movement compared with a group of typically developing children. The measure ranges from 0° to infinity. The measure is expressed in degrees. The higher the measure, the more abnormal the deviation is.
Measured: Baseline and 2 weeks after
Secondary outcomes (15)
Kinematics
Joint angular values, in degrees
Measured: Baseline and 2 weeks after
Movement quality - smoothness
A movement features obtained with 3D motion analysis (spectral arc length). No unit
Measured: Baseline and 2 weeks after
Movement quality - trajectory
A movement features obtained with 3D motion analysis (index of curvature), in degrees
Measured: Baseline and 2 weeks after
Spatiotemporal - velocity
A movement features obtained with 3D motion analysis. Velocity, in meter/seconds
Measured: Baseline and 2 weeks after
Spatiotemporal - duration
A movement features obtained with 3D motion analysis. Duration in seconds
Measured: Baseline and 2 weeks after
Electromyography
muscle activity in microVolt
Measured: Baseline and 2 weeks after
Muscle strength
Muscle strength will be evaluated using the Medical Research Council scale (Paternostro-Sluga et al., 2008), a six-point ordinal scale from 0 to 5 in which 0 indicates no muscle contraction and 5 indicates normal strength. A composite strength score will be defined as the sum of the muscle weakness scores (total score: 0-80).
Measured: 1 day
Muscle spasticity
Muscle spasticity will be evaluated with the Modified Ashworth Scale (MAS) (Mutlu et al., 2008), a six-point ordinal scale, rating from 0 to 4 (possible scores: 0,1,1+,2,3,4). A score of 0 represents normal muscle tone, whereas a score of 4 corresponds to no possible movement due to rigidity. A composite spasticity score, rated from 0 to 5, will be defined as the sum of MAS scores for each child (total score: 0-80 [16 muscles × 5 levels]).
Measured: 1 day
Muscle selectivity
Muscle selectivity was evaluated using selective motor control (SMC) (Masson, n.d.), a five-point ordinal scale from 0 to 2, in increments of 0.5, in which a score of 2 corresponded to normal selectivity. A composite selectivity score was defined as the sum of the muscle selectivity scores (total score: 0-32).
Measured: 1 day
Melbourne Assessment Test
It is a valid and reliable criterion-referenced test of impaired upper limb movement quality. The final score is reported as 4 separate sub-scores, 1 for each item of movement quality, reported on a scale from 0-100%, where 100% corresponds to full functional capacity.
Measured: 1 day
Assisting Hand Assessment (AHA)
It is video recorded and rated using video-based scoring. It involves the evaluation of 22 bimanual activities. The total score ranges from 0 to 100 AHA-units; 100 AHA-units indicates normal spontaneous use of the impaired hand.
Measured: 1 day
Abilhand-Kids
It is a questionnaire of bimanual daily life activities addressed to parents. Parents are asked to rate their child's difficulty on a 3-level scale (range from 0 to 2) for 21 items. The manual ability scale is calibrated in logits (i.e., log-odds units).
Measured: 1 day
Short Feedback Questionnaire
It is a short post-immersive and presence questionnaire containing only six questions. Each item is rated from 0 to 5 (1 = not at all ; 5 = very much)
Measured: 1 day
User Satisfaction Evaluation Questionnaire
It is a questionnaire developed in order to evaluate user satisfaction with rehabilitation systems. It comprises six questions that can be rated on a Likert scale ranging from 1 (not at all) to 5 (very much).
Measured: 1 day
System Usability Scale
It is a questionnaire of usability. It is composed of 10 items. Only for the purpose of this study, the word "interface" in the items has been used interchangeably with the word "game". Each item's score ranged from 0 to 4. For items 1, 3, 5, 7 and 9 (odd-numbered items) the score contribution was the scale position minus 1. For items 2, 4, 6, 8 and 10 (even-numbered items) the score contribution was 5 minus the scale position. Next, we multiplied the sum of scores by 2.5 to obtain the overall System Usability value. SUS scores range from 0 to 100.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study startFeb 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marine Cacioppo, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774456
- Sponsor's protocol ID
- 2024-02423
- Acronym
- Play2BEAPI
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cacioppo M, Loos A, Lempereur M, Brochard S. Bimanual movements in children with cerebral palsy: a systematic review of instrumented assessments. J Neuroeng Rehabil. 2023 Feb 27;20(1):26. doi: 10.1186/s12984-023-01150-7.
PubMed 36849971Gaillard F, Cacioppo M, Bouvier B, Bouzille G, Newman CJ, Pasquet T, Cretual A, Rauscent H, Bonan I. Assessment of bimanual performance in 3-D movement analysis: Validation of a new clinical protocol in children with unilateral cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):408-415. doi: 10.1016/j.rehab.2019.06.008. Epub 2019 Jul 10.
PubMed 31301386Cacioppo M, Lempereur M, Houx L, Bouvier S, Bailly R, Brochard S. Detecting Movement Changes in Children with Hemiparesis after Upper Limb Therapies: A Responsiveness Analysis of a 3D Bimanual Protocol. Sensors (Basel). 2023 Apr 24;23(9):4235. doi: 10.3390/s23094235.
PubMed 37177439Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.
PubMed 33091791
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a 3D Motion Analysis Protocol With an Instrumented Game to Evaluate Upper Limb Impairments in Children With Neuromotor Disorders
- ClinicalTrials.gov ID
- NCT06774456
- Acronym / sponsor ID
- Play2BEAPI / 2024-02423
- Keywords
- Children, upper limb, motion analysis, serious game, neuromotor disorders, bimanual function, electromyography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 14 Jan 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.
The goal of this clinical trial is to validate an instrumented 3D serious game to assess upper limb impairments in children with neuromotor disorders. The main questions are:
- Does an instrumented 3D serious game can provide a set of validated upper limb movement features with good reliability, validity and responsiveness ?
- Does the instrumented 3D serious game could provide better immersion, adhesion, usability and satisfaction than a "classic" 3D protocol, thanks to the developped environment ?
Researchers will compare children with neuromotor disorders and typically developing children to assess discriminant validity of the new assessement.
Children with neuromotor disorders will have 2 visits to the hospital :
- Visit 1 : children will perform a validated 3D protocol and the instrumented 3D serious game
- Visit 2 : children will have a clinical examination and will perform the instrumented 3D serious game
Typically developing children will have one visit to the hospital. They will perform the instrumented 3D serious game.
Detailed description
The instrumented 3D serious game (BE API 3.0) will be performed during a 3D motion analysis session. It is composed of:
- One screen (35 pouces)
- Game set up (2-handed joystick, turbo, shifter, dashboard, box, coins and buzzer) instrumented with sensors to link the game and measure grasp strength.
- Software: Unity software (version 2022.3.21f1, Unity Technologies, San Francisco, California, USA)
The game is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the UL and trunk, and he/she can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with neuromotor disorders | Other | Device: instrumented 3D serious game (BE API 3.0)During Visit 1, children will perform both a validated 3D protocol and the instrumented 3D serious game (developed version). After each session, questionnaires will be distributed to participants to assess the added value of the immersive environment. During Visit 2, children will have a clinical examination (goniometry, muscle strength, spasticity, motor selectivity) and functional assessments by experienced therapists at hospital and will perform the instrumented 3D serious game. |
| Typically developing children | Other | Device: instrumented 3D serious game (BE API 3.0)Children will have one visit to the hospital (Visit 1). They will perform the instrumented serious game, in order to assess the discriminant validity of the upper limb movement features between children with neuromotor disorders and typically developing children. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children with NMD
- TD children
Key exclusion criteria (7 listed)
- Children with neuromotor disorders
- TD children
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 |
|---|---|---|
| instrumented 3D serious game (BE API 3.0)Also: Clinical and functional tests, Validated 3D protocol (old version), QuestionnairesIt is composed of bimanual tasks integrated into a game scenario. The child is first equipped with markers on the upper limb (UL) and trunk (3D motion analysis and electromyography), and he/she can then play the game. There are several tasks ('piloting missions') to evaluate specific UL movements. The UL movements are recorded when the child is playing. The instruments of the set-up (wheel, turbo, etc.) are connected to the game to play and can also be used as measurements (grip strength, etc.). The markers are then removed. The total duration of the game is about 30-45 minutes, including placing/removing markers and the game. | Device | Children with neuromotor disorders, Typically developing children |
Primary outcome
Arm Profile Score
Time frame: Baseline and 2 weeks after
A kinematic index (upper limb movement feature) which reflects the severity of the deviations of the subject's movement compared with a group of typically developing children. The measure ranges from 0° to infinity. The measure is expressed in degrees. The higher the measure, the more abnormal the deviation is.
15 secondary outcomes
Kinematics
Time frame: Baseline and 2 weeks after
Movement quality - smoothness
Time frame: Baseline and 2 weeks after
Movement quality - trajectory
Time frame: Baseline and 2 weeks after
Spatiotemporal - velocity
Time frame: Baseline and 2 weeks after
Spatiotemporal - duration
Time frame: Baseline and 2 weeks after
Electromyography
Time frame: Baseline and 2 weeks after
Muscle strength
Time frame: 1 day
Muscle spasticity
Time frame: 1 day
Muscle selectivity
Time frame: 1 day
Melbourne Assessment Test
Time frame: 1 day
Assisting Hand Assessment (AHA)
Time frame: 1 day
Abilhand-Kids
Time frame: 1 day
Short Feedback Questionnaire
Time frame: 1 day
User Satisfaction Evaluation Questionnaire
Time frame: 1 day
System Usability Scale
Time frame: 1 day
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 14 Jan 2025.
- Background: PubMed 36849971Cacioppo M, Loos A, Lempereur M, Brochard S. Bimanual movements in children with cerebral palsy: a systematic review of instrumented assessments. J Neuroeng Rehabil. 2023 Feb 27;20(1):26. doi: 10.1186/s12984-023-01150-7.
- Background: PubMed 31301386Gaillard F, Cacioppo M, Bouvier B, Bouzille G, Newman CJ, Pasquet T, Cretual A, Rauscent H, Bonan I. Assessment of bimanual performance in 3-D movement analysis: Validation of a new clinical protocol in children with unilateral cerebral palsy. Ann Phys Rehabil Med. 2020 Oct;63(5):408-415. doi: 10.1016/j.rehab.2019.06.008. Epub 2019 Jul 10.
- Background: PubMed 37177439Cacioppo M, Lempereur M, Houx L, Bouvier S, Bailly R, Brochard S. Detecting Movement Changes in Children with Hemiparesis after Upper Limb Therapies: A Responsiveness Analysis of a 3D Bimanual Protocol. Sensors (Basel). 2023 Apr 24;23(9):4235. doi: 10.3390/s23094235.
- Background: PubMed 33091791Cacioppo M, Marin A, Rauscent H, Le Pabic E, Gaillard F, Brochard S, Garlantezec R, Cretual A, Bonan I. A new child-friendly 3D bimanual protocol to assess upper limb movement in children with unilateral cerebral palsy: Development and validation. J Electromyogr Kinesiol. 2020 Dec;55:102481. doi: 10.1016/j.jelekin.2020.102481. Epub 2020 Oct 10.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instrumented 3D serious game (BE API 3.0) in people with Cerebral Palsy and Brain Injury, run by University Hospital, Geneva at 1 site in Switzerland.
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 7 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: opening soon, as of the sponsor's last update on 14 Jan 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 Switzerland. 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 Marine Cacioppo, MD, PhD (+41 79 553 84 67, marine.cacioppo@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm Profile Score (time frame: Baseline and 2 weeks after). 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 NCT06774456, which also lists 4 linked publications.
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 14 Jan 2025.