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Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

14. Mai 2026 aktualisiert von: Elcin Akyurek

Impact of Early Postoperative Mobilization on Equinus Correction in Spastic Cerebral Palsy

The aim of this study is to investigate the effect of early postoperative mobilization on the correction of equinus deformity and the improvement of motor functions following gastrotenotomy in children with spastic-type Cerebral Palsy (CP).

H1: Early postoperative mobilization combined with AFO use after gastrotenotomy in children with spastic CP has a significant effect on equinus correction and motor function improvement.

H0: Early postoperative mobilization combined with AFO use after gastrotenotomy in children with spastic CP has no significant effect on equinus correction or motor function improvement.

The study is designed as a prospective, comparative clinical investigation. Children aged 4-14 years with spastic-type CP and Gross Motor Function Classification System (GMFCS) levels I-II will be included. Participants will be randomly assigned into two groups:

Group 1: A cast will be applied for 3 weeks postoperatively, followed by 24-hour AFO use for 3 weeks, and thereafter night-time use only. A rehabilitation program will be initiated for 12 weeks postoperatively, twice per week.

Group 2: AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only. Early postoperative rehabilitation will be provided twice per week for 12 weeks.

Assessments will be conducted preoperatively and at postoperative months 3, 6, and 12. The Gross Motor Function Measure-88 (GMFM-88) and the Edinburgh Visual Gait Score will be used as measurement tools.

Gastrotenotomy is a commonly preferred surgical technique in children with spastic CP; however, there is no consensus regarding the optimal duration of postoperative immobilization or the appropriate timing of mobilization. Early mobilization has been reported to have beneficial effects on muscle-tendon flexibility, joint range of motion, and gait pattern.

The findings of this study are expected to contribute to the evidence-based standardization of rehabilitation protocols following gastrotenotomy, and to provide scientific insight into the safety and effectiveness of early mobilization. The results may support clinicians in developing more functional and time-efficient postoperative rehabilitation programs.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Cerebral Palsy (CP) is a condition characterized by a permanent motor function impairment resulting from brain injury occurring before, during, or after birth. Spastic CP accounts for approximately 70-80% of all cases, and equinus deformity is the most common deformity in the lower extremities due to increased muscle tone. Equinus deformity leads to limited ankle dorsiflexion and gait abnormalities, thereby negatively affecting functional independence. Gastrotenotomy is frequently performed in the surgical management of this deformity; however, there is no consensus in the literature regarding the duration of postoperative immobilization, AFO-use protocols, or the optimal timing of mobilization.

Early postoperative mobilization is suggested to support the remodeling of the muscle-tendon unit, increase joint range of motion, and prevent muscle shortening and contracture development. Nevertheless, controlled studies investigating the effect of early mobilization on equinus correction following gastrotenotomy in children with CP are highly limited. Therefore, the aim of this study is to evaluate the effects of early postoperative mobilization on equinus deformity correction and gross motor function improvement in children with spastic-type CP. The results are expected to contribute to the standardization of postoperative rehabilitation protocols and to support evidence-based decision-making in clinical practice.

Studientyp

Interventionell

Einschreibung (Geschätzt)

42

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

  1. Diagnosis: Children diagnosed with spastic-type Cerebral Palsy (CP).
  2. Age Range: Participants aged between 4 and 14 years.
  3. Functional Level: Children with Gross Motor Function Classification System (GMFCS) levels I-II (able to walk independently or with minimal assistance).
  4. Surgical Indication: Scheduled for orthopedic surgery (gastrotenotomy) due to equinus deformity.
  5. Cognitive Status: Sufficient cognitive capacity to understand verbal instructions.
  6. Parental Consent: Written informed consent obtained from parents or legal guardians.

Exclusion Criteria

  1. Other CP Types: Children diagnosed with dyskinetic, ataxic, or mixed-type CP.
  2. Functional Level: Participants with GMFCS levels III, IV, or V (unable to walk independently or dependent on a wheelchair).
  3. Concomitant Orthopedic Problems: Presence of hip dysplasia, scoliosis, or severe lower extremity contractures that may affect gait patterns.
  4. Neuromuscular or Other Diseases: Presence of non-CP neuromuscular disorders (e.g., muscular dystrophy, peripheral neuropathy).
  5. Previous Surgery: History of tendon lengthening or muscle release surgery in the same lower extremity.
  6. Postoperative Complications: Development of surgical site infection, excessive pain, or conditions requiring reoperation.
  7. Noncompliance with Rehabilitation: Inability to attend prescribed physical therapy and rehabilitation sessions regularly or poor adherence to the treatment program.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Group 1 (Cast Group)
Group 1 (Cast Group): A cast will be applied for 3 weeks postoperatively, followed by 24-hour AFO use for 3 weeks, and thereafter only night-time use will be maintained. A physiotherapist-supervised physical therapy and rehabilitation program will be initiated twice weekly for 12 weeks postoperatively.
Verfahren: Gastro Tenotomy
All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Sonstiges: Exercise
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Aktiver Komparator: Group 2 (AFO Group)
AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only. A physiotherapist-supervised physical therapy and rehabilitation program will be initiated twice weekly for 12 weeks postoperatively.
Verfahren: Gastro Tenotomy
All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Sonstiges: Exercise
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Gerät: ankle foot orthosis
Group 1 (Cast Group): A cast will be applied for 3 weeks postoperatively, followed by Group 2 (AFO Group): AFO will be used 24 hours a day for 6 weeks postoperatively, followed by night-time use only.
Andere Namen:
  • early intervention

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Gross Motor Function Measure-88 (GMFM-88)
Zeitfenster: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month

The Gross Motor Function Measure-88 (GMFM-88) is a standardized, criterion-referenced observational assessment tool designed to evaluate changes in gross motor function in children with motor impairments, particularly those with Cerebral Palsy. The instrument consists of 88 items distributed across five dimensions: (A) lying and rolling, (B) sitting, (C) crawling and kneeling, (D) standing, and (E) walking, running, and jumping. Each item is scored on a 4-point ordinal scale based on the child's ability to initiate, partially perform, or fully complete the task.

The GMFM-88 is widely recognized for its sensitivity to clinically meaningful changes in motor performance and is frequently used in both research and clinical settings to monitor functional progress, evaluate treatment outcomes, and compare motor capacities across time.
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
Edinburgh Visual Gait Score (EVGS)
Zeitfenster: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month
The Edinburgh Visual Gait Score (EVGS) is a clinical tool used to assess gait abnormalities in children with cerebral palsy. It provides a quantitative evaluation of 17 kinematic parameters of both lower limbs, scored based on video recordings of the child walking. Each parameter is rated on an ordinal scale, allowing clinicians and researchers to objectively monitor gait deviations, evaluate treatment outcomes, and track changes over time.
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month

Mitarbeiter und Ermittler

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

Sponsor

Elcin Akyurek

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. Oktober 2026

Studienabschluss (Geschätzt)

30. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

14. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Mai 2026

Zuerst gepostet (Tatsächlich)

20. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AkyurekE5

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

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