Cerebral PalsyNCT07601165
Soft Tissue Release for Elbow Pronation in Cerebral Palsy
A study testing Upper extremity soft-tissue release in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Upper extremity soft-tissue release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- History of previous upper-extremity surgery
- History of progressive neurological disease
- Cognitive or physical capacity insufficient to complete the assessment tools
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy
- Being tested
- Upper extremity soft-tissue release
- Keywords
- cerebral palsy, upper extremity, function, release surgery
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity soft-tissue releaseProcedure or surgery
Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release
| Study group | Role | What they receive |
|---|---|---|
| surgery | Other | Upper extremity soft-tissue release Receives: Procedure: Upper extremity soft-tissue release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 times (pre-operative, 6.month, 12 month, 18 month, 24 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elcin Akyurek, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601165
- Sponsor's protocol ID
- AkyurekE4
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Soft Tissue Release for Elbow Pronation Deformity in Cerebral Palsy: Functional Outcomes
- ClinicalTrials.gov ID
- NCT07601165
- Acronym / sponsor ID
- AkyurekE4
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, upper extremity, function, release surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Other | Procedure: Upper extremity soft-tissue releaseUpper extremity soft-tissue release |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- History of previous upper-extremity surgery
- History of progressive neurological disease
- Cognitive or physical capacity insufficient to complete the assessment tools
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Upper extremity soft-tissue releaseSurgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release | Procedure or surgery | surgery |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Upper extremity soft-tissue release in people with Cerebral Palsy, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
House Classification (time frame: 5 times (pre-opperative, 6. month, 12. month, 18. month, 24. month)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.