このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

Soft Tissue Release for Elbow Pronation in Cerebral Palsy

2026年5月20日 更新者:Elcin Akyurek、Istanbul University - Cerrahpasa

Distal Soft Tissue Release for Elbow Pronation Deformity in Cerebral Palsy: Functional Outcomes

Upper extremity deformities are highly common in individuals with cerebral palsy (CP) as a result of motor control impairment and muscle imbalance. Among these deformities, elbow pronation deformities are frequently observed, particularly in spastic-type CP (Koman et al., 2004). The imbalance between the pronator muscle group (pronator teres, pronator quadratus) and the supinator muscle group (supinator, biceps brachii) leads to the forearm remaining in a persistent pronated position (Sahoo et al., 2017). This deformity is not only aesthetically concerning but also results in significant functional limitations. Both fine and gross motor skills-such as washing the face, handshaking, and clapping-are adversely affected (Soutar & McComas, 1990). Additionally, children may experience difficulty using assistive devices such as walkers, which in turn can negatively impact ambulation (Flett, 2003).

An elbow fixed in pronation forces children to compensate for limited range of motion by using shoulder and trunk movements, which over time predisposes them to abnormal postural development (Gracies, 2005). In advanced cases, structural alterations such as posterolateral radial head dislocations may also occur (Van Heest & House, 2000). Both conservative (orthoses, botulinum toxin injections, physical therapy) and surgical interventions are employed in the treatment of pronation deformities. Surgical options include tenotomy of the pronator teres and pronator quadratus, muscle transfers, or combined procedures (Zancolli, 1975). However, there is no consensus in the literature regarding which surgical method should be applied to which patient group and at what stage (House et al., 1981).

The aim of this study is to evaluate the effects of distal soft-tissue release surgery for the treatment of elbow pronation deformity on upper extremity function in children with cerebral palsy.

調査の概要

状態

まだ募集していません

条件

詳細な説明

The aim of this study is to evaluate the effects of distal soft-tissue release surgery, performed for elbow pronation deformity in children with Cerebral Palsy (CP), on upper extremity functions. By comparing pre-operative and post-operative measurements, the study will determine the presence and extent of functional improvement.

  • H1:** Distal soft-tissue release surgery performed for elbow pronation deformity in children with Cerebral Palsy has a significant effect on upper extremity functions.
  • H0:** Distal soft-tissue release surgery has no significant effect on upper extremity functions.

This study will be conducted as a prospective, observational study with long-term follow-up after the intervention.

A total of 20 children aged 6-16 years, diagnosed with spastic-type CP and scheduled for surgery due to forearm pronation deformity, will be included. Participants will undergo distal soft-tissue release targeting the pronator quadratus muscle (Zancolli, 1975; Van Heest & House, 2000). The upper extremity functional level of participants will be assessed using the **HOUSE Classification**; motor abilities using the **Manual Ability Classification System (MACS)**; motor quality using the **Quality of Upper Extremity Skills Test (QUEST)**; range of motion using **goniometric measurements**; function and aesthetics using the **Shriners Hospital Upper Extremity Evaluation (SHUEE)**; hand skills using the **Bimanual Fine Motor Function Test (BFMF)**; and quality of life using the **Pediatric Quality of Life Inventory (PedsQL)**. Assessments will be performed preoperatively and at six-month intervals for two years following surgery.

Data will be analyzed using SPSS software, with the significance level set at p < 0.05.

Although the literature includes various descriptive studies on the functional effects of pronation deformity in children with CP (Koman et al., 2004; Gracies, 2005), there is a limited number of studies evaluating the functional outcomes of distal soft-tissue interventions for this deformity (Sahoo et al., 2017). By objectively assessing the impact of surgical intervention on daily living activities and social participation, this research aims to contribute evidence-based insights to clinical decision-making processes. Moreover, the study aims to highlight the importance of function-oriented interventions for individuals with CP who experience upper extremity deformities, thereby providing data to support appropriate patient selection and timing of intervention in the early period.

研究の種類

介入

入学 (推定)

28

段階

  • 適用できない

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Being between 6 and 16 years of age,
  • Having a diagnosis of spastic-type cerebral palsy,
  • presenting with an elbow pronation deformity requiring surgical intervention,
  • obtaining consent from the parent/guardian

Exclusion Criteria:

  • History of previous upper-extremity surgery
  • History of progressive neurological disease
  • Cognitive or physical capacity insufficient to complete the assessment tools

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
他の:surgery
Upper extremity soft-tissue release
Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release

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
House Classification
時間枠:5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Upper extremity function will be assessed using the House Functional Classification System. The scale classifies spontaneous use of the affected upper extremity during daily activities into 9 levels (0-8), where higher scores indicate better upper extremity function.
5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Manual Ability Classification System
時間枠:5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Manual ability will be assessed using the Manual Ability Classification System (MACS), a 5-level classification system evaluating how children use their hands to handle objects in daily activities. Level I indicates the best manual ability and Level V indicates the most severe limitation.
5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Quality of Upper Extremity Skills Test
時間枠:5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Upper extremity motor skill quality will be assessed using the Quality of Upper Extremity Skills Test (QUEST). The assessment evaluates dissociated movements, grasp, weight bearing, and protective extension. Scores range from 0 to 100, with higher scores indicating better upper extremity motor performance.
5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Gonyometer
時間枠:5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Upper extremity range of motion will be measured in degrees using a standard universal goniometer. Shoulder, elbow, wrist, and forearm joint motions will be evaluated. Higher degree values indicate greater joint range of motion.
5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Shriners Hospital Upper Extremity Evaluation
時間枠:5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Upper extremity function will be assessed using the Shriners Hospital Upper Extremity Evaluation (SHUEE), which evaluates spontaneous functional analysis, dynamic positional analysis, and grasp/release abilities during task performance. Higher scores indicate better upper extremity function.
5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)
Bimanual Fine Motor Function testi
時間枠:5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)
Bimanual fine motor function will be assessed using the Bimanual Fine Motor Function (BFMF) classification system. The BFMF evaluates fine motor abilities of both hands separately during object manipulation and daily activities. The classification consists of 5 levels, where Level I indicates normal fine motor function and Level V indicates severe impairment in bimanual fine motor abilities.
5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)
Pediatric Quality of Life Inventory
時間枠:5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL). The PedsQL is a standardized questionnaire evaluating physical, emotional, social, and school functioning in children and adolescents. Total scores range from 0 to 100, with higher scores indicating better health-related quality of life.
5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月30日

一次修了 (推定)

2026年8月30日

研究の完了 (推定)

2028年1月30日

試験登録日

最初に提出

2026年5月14日

QC基準を満たした最初の提出物

2026年5月20日

最初の投稿 (実際)

2026年5月22日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月22日

QC基準を満たした最後の更新が送信されました

2026年5月20日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • AkyurekE4

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?

いいえ

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

いいえ

米国FDA規制機器製品の研究

いいえ

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。

購読する