- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: BEURIAT PA PA, MD
- Telefonní číslo: 0472357572
- E-mail: pierre-aurelien.beuriat@chu-lyon.fr
Studijní místa
-
-
-
Bron, Francie
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
-
Vrchní vyšetřovatel:
- Pierre-Aurélien BEURIAT, MD
-
Kontakt:
- Pierre-Aurélien BEURIAT
- Telefonní číslo: 0472357572
- E-mail: pierre-aurélien.beuriat@chu-lyon.fr
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Melbourne Test - Version 2 (MA2).
Časové okno: 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). |
Data are collected preoperatively and at 12-15 months postoperatively.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 26-5027
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .