Cerebral PalsyValid-ABLENCT07432789
Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy
A study testing Assessment of functional abilities, Children's self-questionnaires and Parent self-assessment questionnaires in people with Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Assessment of functional abilities, Children's self-questionnaires and Parent self-assessment questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 18 Mar 2026to 16 Nov 2028
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Common to both groups:
- Obtaining free and informed consent from the child and at least one parent
- Children of all genders aged 6 to 18
- Children affiliated with or beneficiaries of a social security system
- For the Cerebral Palsy group:
- Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;
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- Unilateral and bilateral impairment;
- Gross Motor Function Classification System (GMFCS) = I to III;
- No major cognitive or visual impairments that limit the performance of motor tasks
- For the control group:
- Children free from any disease
- Other volunteers included in the protocol (qualitative analysis only (parents and clinicians)):
- Parent(s) of children with CP included in this study;
- Healthcare professionals and researchers involved in monitoring children with CP and/or evaluating the research application within the framework of this study
Who cannot join
- Common to both groups:
- Participants or parent(s) of participants who do not speak French
- Children subject to legal protection measures
- Pregnant or breastfeeding participants
- For the Cerebral Palsy group:
- Presence of a cause of neuro-orthopedic disorders other than CP
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- Limiting pain
- Surgical procedures performed less than 6 months prior to inclusion in the study
- Any other functional medical intervention that took place 3 months prior to inclusion in the study (e.g., botulinum toxin injections, plaster casts, etc.)
- Medical or surgical interventions planned between visit 1 and visit 2
- Children with a condition other than cerebral palsy that affects their walking ability
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
Chu Dijon Bourgogne
Dijon, 21000
Paul ORNETTI, 03.80.29.38.72 ext. +33, paul.ornetti@chu-dijon.fr
About this study
Cerebral palsy is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children.
Currently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.
- Conditions
- Cerebral Palsy
- Being tested
- Assessment of functional abilities, Children's self-questionnaires, Parent self-assessment questionnaires, Semi-structured interview
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of functional abilitiesOther
Gold standard
Children's self-questionnairesOther
ABILOCO-Kids
Parent self-assessment questionnairesOther
GOAL
Semi-structured interviewOther
Interview
Assessment of functional abilitiesOther
Application
| Study group | Role | What they receive |
|---|---|---|
| Children with a medical diagnosis of cerebral palsy as defined by SCPE | Experimental | Not described Receives: Other: Assessment of functional abilities; Other: Children's self-questionnaires; Other: Parent self-assessment questionnaires; Other: Semi-structured interview |
| Healthy volunteers | Active comparator | Not described Receives: Other: Assessment of functional abilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
Measured: Up to 8 months
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start18 Mar 2026
- Primary completion16 Nov 2028 (estimated)
- Study completion16 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432789
- Sponsor's protocol ID
- GUEUGNON THCS 2024
- Acronym
- Valid-ABLE
- Status last verified
- Apr 2026
- First submitted
- 10 Feb 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metrological Properties of a Digital Motion Analysis Research Application for Assessing the Motor Abilities and Performance of Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07432789
- Acronym / sponsor ID
- Valid-ABLE / GUEUGNON THCS 2024
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 16 Nov 2028 (estimated)
- Study completion
- 16 Nov 2028 (estimated)
- First posted
- 25 Feb 2026 (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 is a common neurological disorder that is the leading cause of motor disability in children. It causes significant motor impairments, affecting various aspects such as fine and gross motor skills, as well as locomotion, which has a major impact on the quality of life of affected children. It is therefore essential to characterize these functional impairments in order to guide clinical decisions and maximize the motor function of affected children.
Currently, the assessment of motor function is based on physical examinations and functional scales, such as the Gross Motor Function Classification System, which is specifically designed to assess children with CP. However, movement analysis using optoelectronic systems is considered the gold standard for this assessment, even though these systems have notable limitations (expensive installation, time-consuming use, and use only in a clinical environment, making it difficult to assess motor skills in children's everyday lives). In order to establish a comprehensive and personalized functional diagnosis, it is crucial to evaluate other fundamental motor tasks such as running, jumping, object control, and balance tasks. Recently, innovative markerless motion analysis technologies have been developed that allow analysis using smartphones or tablets outside of healthcare facilities. Therefore, developing an application dedicated to motion analysis for children with cerebral palsy that is easy to access and can be used frequently could yield many significant benefits.
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 a medical diagnosis of cerebral palsy as defined by SCPE | Experimental | Other: Assessment of functional abilities, Other: Children's self-questionnaires, Other: Parent self-assessment questionnaires, Other: Semi-structured interview |
| Healthy volunteers | Active comparator | Other: Assessment of functional abilities |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- Obtaining free and informed consent from the child and at least one parent
- Children of all genders aged 6 to 18
- Children affiliated with or beneficiaries of a social security system
- Medical diagnosis of CP according to the SCPE (Surveillance of Cerebral Palsy in Europe) definition;
- Unilateral and bilateral impairment;
Key exclusion criteria (11 listed)
- Participants or parent(s) of participants who do not speak French
- Children subject to legal protection measures
- Pregnant or breastfeeding participants
- Presence of a cause of neuro-orthopedic disorders other than CP
- Limiting pain
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 |
|---|---|---|
| Assessment of functional abilitiesGold standard | Other | Children with a medical diagnosis of cerebral palsy as defined by SCPE, Healthy volunteers |
| Children's self-questionnairesABILOCO-Kids | Other | Children with a medical diagnosis of cerebral palsy as defined by SCPE |
| Parent self-assessment questionnairesGOAL | Other | Children with a medical diagnosis of cerebral palsy as defined by SCPE |
| Semi-structured interviewInterview | Other | Children with a medical diagnosis of cerebral palsy as defined by SCPE |
| Assessment of functional abilitiesApplication | Other | Children with a medical diagnosis of cerebral palsy as defined by SCPE, Healthy volunteers |
Primary outcome
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software
Time frame: Up to 8 months
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using the Gold Standard system (Motion Capture System).
Time frame: Up to 8 months
We will measure the left and right knees, which will be classified as either the most affected lower limb or the least affected lower limb in the PC group.
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 17 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment of functional abilities, Children's self-questionnaires and Parent self-assessment questionnaires in people with Cerebral Palsy, run by Centre Hospitalier Universitaire Dijon 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 14 inclusion and 11 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 17 Apr 2026. 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?
Contact Paul ORNETTI (03.80.29.38.72 ext. +33, paul.ornetti@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angle (in degrees) of knee flexion in sagittal view during a two-foot vertical jump using digital motion analysis software (time frame: Up to 8 months). The study lists 2 primary outcomes in all. 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 17 Apr 2026.