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NCT Number: NCT07601165

Soft Tissue Release for Elbow Pronation in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Upper extremity soft-tissue release

Procedure

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

Primary outcomes

  1. House Classification

    Time frame: 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.

  2. Manual Ability Classification System

    Time frame: 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.

  3. Quality of Upper Extremity Skills Test

    Time frame: 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.

  4. Gonyometer

    Time frame: 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. Shriners Hospital Upper Extremity Evaluation

    Time frame: 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.

  6. Bimanual Fine Motor Function testi

    Time frame: 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.

  7. Pediatric Quality of Life Inventory

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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