- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07915466
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy. (PN-ULCP)
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.
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.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: BEURIAT PA PA, MD
- Numer telefonu: 0472357572
- E-mail: pierre-aurelien.beuriat@chu-lyon.fr
Lokalizacje studiów
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Bron, Francja
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
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Główny śledczy:
- Pierre-Aurélien BEURIAT, MD
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Kontakt:
- Pierre-Aurélien BEURIAT
- Numer telefonu: 0472357572
- E-mail: pierre-aurélien.beuriat@chu-lyon.fr
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
Inclusion Criteria:
- Age < 18 years at the time of surgery.
- Unilateral or bilateral upper limb impairment.
- Follow-up at the CMCR des Massues.
- Inclusion between 1 February 2018 and 31 October 2025.
Exclusion Criteria:
- Refusal to allow medical data to be used for research purposes.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: RETROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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. |
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Melbourne Test - Version 2 (MA2).
Ramy czasowe: Data are collected preoperatively and at 12-15 months postoperatively.
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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). |
Data are collected preoperatively and at 12-15 months postoperatively.
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 26-5027
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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