Soft Tissue Release for Elbow Pronation in Cerebral Palsy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Upper extremity soft-tissue release
  Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release

Первичные конечные точки

• House Classification [Срок оценки: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)]
• Manual Ability Classification System [Срок оценки: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)]
• Quality of Upper Extremity Skills Test [Срок оценки: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)]
• Gonyometer [Срок оценки: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)]
• Shriners Hospital Upper Extremity Evaluation [Срок оценки: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)]
• Bimanual Fine Motor Function testi [Срок оценки: 5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)]
• Pediatric Quality of Life Inventory [Срок оценки: 5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07601165 · AkyurekE4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗