Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Gastro Tenotomy
  All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
• Устройство 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.
• Другое Exercise
  Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.

Первичные конечные точки

• Gross Motor Function Measure-88 (GMFM-88) [Срок оценки: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month]
• Edinburgh Visual Gait Score (EVGS) [Срок оценки: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07598604 · AkyurekE5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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