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Soft Tissue Release for Elbow Pronation in Cerebral Palsy

20 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

28

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: surgery
Upper extremity soft-tissue release
Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
House Classification
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

30 de junho de 2026

Conclusão Primária (Estimado)

30 de agosto de 2026

Conclusão do estudo (Estimado)

30 de janeiro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

14 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de maio de 2026

Primeira postagem (Real)

22 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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