Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Soft Tissue Release for Elbow Pronation in Cerebral Palsy

20. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

28

Phase

  • Unzutreffend

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: surgery
Upper extremity soft-tissue release
Surgical tenotomy of the pronator teres and pronator quadratus muscles accompanied by distal soft-tissue release

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
House Classification
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

30. Juni 2026

Primärer Abschluss (Geschätzt)

30. August 2026

Studienabschluss (Geschätzt)

30. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2026

Zuerst gepostet (Tatsächlich)

22. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Zerebralparese

Abonnieren