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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy. (PN-ULCP)

29 oktober 2026 uppdaterad av: Hospices Civils de Lyon

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.

Studieöversikt

Studietyp

Observationell

Inskrivning (Beräknad)

21

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

      • Bron, Frankrike
        • Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
        • Huvudutredare:
          • Pierre-Aurélien BEURIAT, MD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Inte äldre än 18 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: RETROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Melbourne Test - Version 2 (MA2).
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 november 2026

Primärt slutförande (Beräknad)

15 januari 2027

Avslutad studie (Beräknad)

15 juni 2027

Studieregistreringsdatum

Först inskickad

29 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

29 oktober 2026

Första postat (Faktisk)

4 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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OBESLUTSAM

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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