Cerebral Palsy InfantilePN-ULCPNCT07915466
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
An observational study of Cerebral Palsy Infantile and Upper Limb Spasticity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cerebral palsy (CP) is the leading cause of neurological disability in children, with a prevalence of 2-2.5 per 1,000 live births in Europe. It results from irreversible injury to the developing brain and is characterized by permanent disorders of movement and posture, frequently associated with cognitive or sensory… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cerebral Palsy Infantile, Upper Limb Spasticity
- What is being tested?
- Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar).
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2026to 15 Jun 2027
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study includes patients followed at the Massues Medical-Surgical Rehabilitation Centre (Lyon, France) who underwent peripheral neurotomy of the upper limb between February 2018 and October 2025 and who were under 18 years of age at the time of the surgical project. At the Massues Medical-Surgical Rehabilitation Centre, each patient undergoes a preliminary assessment and a surgical plan is defined during a multidisciplinary meeting, with the aim of reaching a shared and informed decision. Peripheral neurotomy surgery is performed by a specialist neurosurgeon, followed by rehabilitation and orthotic treatment tailored to the procedure performed. The impact of the surgery is assessed 12-15 months post-operatively. All patients meeting the inclusion criteria are included, i.e. 21 patients.
Who may be able to join
- Age < 18 years at the time of surgery.
- Unilateral or bilateral upper limb impairment.
- Follow-up at the CMCR des Massues.
Who cannot join
- Refusal to allow medical data to be used for research purposes.
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
Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
Bron
Pierre-Aurélien BEURIAT, 0472357572, pierre-aurélien.beuriat@chu-lyon.fr
Pierre-Aurélien BEURIAT, MD
About this study
Official title: Impact Des Neurotomies Périphériques du Membre supérieur Chez l'Enfant Atteint de Paralysie Cérébrale
Cerebral palsy (CP) is the leading cause of neurological disability in children, with a prevalence of 2-2.5 per 1,000 live births in Europe. It results from irreversible injury to the developing brain and is characterized by permanent disorders of movement and posture, frequently associated with cognitive or sensory impairments. Although the primary lesion is non-progressive, secondary musculoskeletal complications evolve over time, leading to soft tissue contractures and skeletal deformities. Hemiplegia, the most common CP subtype (≈30%), predominantly affects the upper limb, where spasticity and dyskinesia impair both unimanual and bimanual function.
Focal management with botulinum toxin combined with task-oriented therapy has demonstrated functional benefits. However, evidence supporting orthopedic interventions for contractures and deformities remains limited, and functional outcomes following upper limb surgery in CP are insufficiently documented. Selective and hyperselective peripheral neurotomies are established treatments for focal spasticity in adults, yet their role in paediatric CP remains debated.
Read more
To date, no study has systematically compared unilateral and bilateral selective or hyperselective upper limb neurotomies in children with CP, nor analysed medium- and long-term functional trajectories within a structured multidisciplinary decision-making framework. The investigators report the outcomes of a paediatric cohort managed through a standardized pathway including multidimensional preoperative assessment, shared decision-making in a multidisciplinary meeting, specialized neurosurgical intervention, and protocolized postoperative rehabilitation and orthotic management. Functional impact is assessed at discharge and at 6 and 12-15 months.
This study aims to provide original comparative data on the magnitude and durability of functional gains in unimanual and bimanual performance, identify potential responder profiles, and clarify the position of neurotomy within the therapeutic algorithm for the spastic upper limb in children with CP. Ultimately, the findings may contribute to refining indication criteria, optimizing surgical timing, and improving participation and autonomy outcomes.
- Conditions
- Cerebral Palsy Infantile, Upper Limb Spasticity
- Being tested
- Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar).
- Keywords
- Children with Cerebral Palsy, Upper limb spasticity, Peripheral Neurotomies
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar).Procedure or surgery
The peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar) is performed by a specialist neurosurgeon, followed by rehabilitation and orthotic treatment tailored to the procedure performed. The impact of the surgery is assessed at the end of the patient's at 12-15 months, and compared with the preoperative evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Children with cerebral palsy who have undergone a peripheral neurotomy of the upper limb. | Children with cerebral palsy who have undergone a peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar), assessed preoperatively and 12-15 months after surgery, using a standardised battery of tests performed as part of routine clinical practice. Receives: Procedure: Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melbourne Test - Version 2 (MA2).
To mesure the impact of a peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar) in children with CP on range of motion and dexterity.
The range of motion and dexterity scores from the MA2 are used as the main criteria. The MA2 assesses the quality of unilateral upper limb function during standardized tasks (approach, grasping, release, manipulation). It is intended for children aged 2.5 to 15 years with neurological impairment.
The assessment is filmed according to a standardized protocol and scored retrospectively from the video. Four scores expressed as percentages are obtained: range of motion, precision, dexterity, and fluidity of movement. The tool has excellent reliability, both intra- (R = 0.97) and inter-examiner (R = 0.95).
Measured: Data are collected preoperatively and at 12-15 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915466
- Sponsor's protocol ID
- 26-5027
- Acronym
- PN-ULCP
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Des Neurotomies Périphériques du Membre supérieur Chez l'Enfant Atteint de Paralysie Cérébrale
- ClinicalTrials.gov ID
- NCT07915466
- Acronym / sponsor ID
- PN-ULCP / 26-5027
- Conditions
- Cerebral Palsy Infantile, Upper Limb Spasticity
- Keywords
- Children with Cerebral Palsy, Upper limb spasticity, Peripheral Neurotomies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 4 Nov 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 (CP) is the leading cause of neurological disability in children, with a prevalence of 2-2.5 per 1,000 live births in Europe. It results from irreversible injury to the developing brain and is characterized by permanent disorders of movement and posture, frequently associated with cognitive or sensory impairments. Although the primary lesion is non-progressive, secondary musculoskeletal complications evolve over time, leading to soft tissue contractures and skeletal deformities. Hemiplegia, the most common CP subtype (≈30%), predominantly affects the upper limb, where spasticity and dyskinesia impair both unimanual and bimanual function.
Focal management with botulinum toxin combined with task-oriented therapy has demonstrated functional benefits. However, evidence supporting orthopedic interventions for contractures and deformities remains limited, and functional outcomes following upper limb surgery in CP are insufficiently documented. Selective and hyperselective peripheral neurotomies are established treatments for focal spasticity in adults, yet their role in paediatric CP remains debated.
To date, no study has systematically compared unilateral and bilateral selective or hyperselective upper limb neurotomies in children with CP, nor analysed medium- and long-term functional trajectories within a structured multidisciplinary decision-making framework. The investigators report the outcomes of a paediatric cohort managed through a standardized pathway including multidimensional preoperative assessment, shared decision-making in a multidisciplinary meeting, specialized neurosurgical intervention, and protocolized postoperative rehabilitation and orthotic management. Functional impact is assessed at discharge and at 6 and 12-15 months.
This study aims to provide original comparative data on the magnitude and durability of functional gains in unimanual and bimanual performance, identify potential responder profiles, and clarify the position of neurotomy within the therapeutic algorithm for the spastic upper limb in children with CP. Ultimately, the findings may contribute to refining indication criteria, optimizing surgical timing, and improving participation and autonomy outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cerebral palsy who have undergone a peripheral neurotomy of the upper limb. | – | Procedure: Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar).Children with cerebral palsy who have undergone a peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar), assessed preoperatively and 12-15 months after surgery, using a standardised battery of tests performed as part of routine clinical practice. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study includes patients followed at the Massues Medical-Surgical Rehabilitation Centre (Lyon, France) who underwent peripheral neurotomy of the upper limb between February 2018 and October 2025 and who were under 18 years of age at the time of the surgical project. At the Massues Medical-Surgical Rehabilitation Centre, each patient undergoes a preliminary assessment and a surgical plan is defined during a multidisciplinary meeting, with the aim of reaching a shared and informed decision. Peripheral neurotomy surgery is performed by a specialist neurosurgeon, followed by rehabilitation and orthotic treatment tailored to the procedure performed. The impact of the surgery is assessed 12-15 months post-operatively. All patients meeting the inclusion criteria are included, i.e. 21 patients.
Key inclusion criteria (3 listed)
- Age < 18 years at the time of surgery.
- Unilateral or bilateral upper limb impairment.
- Follow-up at the CMCR des Massues.
Key exclusion criteria (1 listed)
- Refusal to allow medical data to be used for research purposes.
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 |
|---|---|---|
| Peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar).The peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar) is performed by a specialist neurosurgeon, followed by rehabilitation and orthotic treatment tailored to the procedure performed. The impact of the surgery is assessed at the end of the patient's at 12-15 months, and compared with the preoperative evaluation. | Procedure or surgery | Children with cerebral palsy who have undergone a peripheral neurotomy of the upper limb. |
Primary outcome
Melbourne Test - Version 2 (MA2).
Time frame: Data are collected preoperatively and at 12-15 months postoperatively.
To mesure the impact of a peripheral neurotomy of the upper limb (musculocutaneous and/or median and/or ulnar) in children with CP on range of motion and dexterity. The range of motion and dexterity scores from the MA2 are used as the main criteria. The MA2 assesses the quality of unilateral upper limb function during standardized tasks (approach, grasping, release, manipulation). It is intended for children aged 2.5 to 15 years with neurological impairment. The assessment is filmed according to a standardized protocol and scored retrospectively from the video. Four scores expressed as percentages are obtained: range of motion, precision, dexterity, and fluidity of movement. The tool has excellent reliability, both intra- (R = 0.97) and inter-examiner (R = 0.95).
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 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Cerebral Palsy Infantile and Upper Limb Spasticity, run by Hospices Civils de Lyon 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 3 inclusion and 1 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 4 Nov 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 BEURIAT PA PA, MD (0472357572, pierre-aurelien.beuriat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melbourne Test - Version 2 (MA2). (time frame: Data are collected preoperatively and at 12-15 months postoperatively.). 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 4 Nov 2026.