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.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：BEURIAT PA PA, MD
- 電話番号：0472357572
- メール：pierre-aurelien.beuriat@chu-lyon.fr
研究場所
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Bron、フランス
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hôpital Femme Mère Enfant - Service de Neurochirurgie Pédiatrique
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主任研究者：
- Pierre-Aurélien BEURIAT, MD
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コンタクト：
- Pierre-Aurélien BEURIAT
- 電話番号：0472357572
- メール：pierre-aurélien.beuriat@chu-lyon.fr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
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.
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Melbourne Test - Version 2 (MA2).
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 26-5027
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。