Soft Tissue Release for Elbow Pronation in Cerebral Palsy
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Jiný: surgery
Upper extremity soft-tissue release
|
Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
House Classification
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- AkyurekE4
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Dětská mozková obrna
-
Kahramanmaras Sutcu Imam UniversityNáborCerebral Palsy Gmfcs-er i-iiTurecko (Türkiye)
-
Clene NanomedicineNational Institute of Neurological Disorders and Stroke (NINDS)Dočasně nedostupnéAmyotrofní laterální skleróza | ALS | PALSSpojené státy
-
Lund UniversityNáborDěti s dětskou mozkovou obrnou, které jsou ambulantní | Cerebral Palsy Gmfcs-er i-iiŠvédsko
-
Auckland City HospitalThe University of Queensland; Auckland Medical Research Foundation; The Australian... a další spolupracovníciAktivní, ne náborMrtvice | Krevní tlak | Embolus CerebralAustrálie, Nový Zéland
-
University of New MexicoUniversity of California, San FranciscoUkončenoCerebrální kavernózní malformaceSpojené státy
-
Recursion Pharmaceuticals Inc.DokončenoCerebrální kavernózní malformaceSpojené státy
-
Beijing Tiantan HospitalZatím nenabírámeCavernózní malformace, cerebrálníČína
-
University of ChicagoMayo Clinic; National Institute of Neurological Disorders and Stroke (NINDS); University of California, San Francisco a další spolupracovníciAktivní, ne náborCerebrální kavernózní malformace | Cavernózní angiom | Hemoragická mikroangiopatieSpojené státy
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Fondazione Policlinico Universitario Agostino Gemelli IRCCS; Mario Negri Institute... a další spolupracovníciNáborFamiliární cerebrální kavernózní malformace | CCMItálie
-
University of California, San FranciscoUniversity of Chicago; National Institute of Neurological Disorders and Stroke... a další spolupracovníciAktivní, ne náborMozkové kavernózní malformace | Cavernózní angiom, familiární | Mozkový kavernózní hemangiomSpojené státy