Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-14
SponsorElcin Akyurek

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Gastro Tenotomy
  • ankle foot orthosis
  • Exercise

Treatment groups

42 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Elcin Akyurek

Lead sponsor

Istanbul University - Cerrahpasa

Sponsor institution