Soft Tissue Release for Elbow Pronation in Cerebral Palsy

NCT07601165 | Not Yet Recruiting

• 1 other identifier: AkyurekE4
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; upper extremity; function; release surgery

Outcome Measures

Primary Outcomes (7)

• House Classification

  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

  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

  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

  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

  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

  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

  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)

Study Arms (1)

surgery

OTHER

Upper extremity soft-tissue release

Procedure: Upper extremity soft-tissue release

Interventions

Upper extremity soft-tissue release PROCEDURE

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

surgery

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physiotherapist

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share