Early Mobilization and Equinus Correction in Spastic Cerebral Palsy
ConditionCerebral 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Gastro Tenotomy
Procedure/SurgeryAll participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
ankle foot orthosis
DeviceGroup 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.
Exercise
Other interventionBoth groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Group 1 (Cast Group)Active comparator 2 interventions
Group B: Group 2 (AFO Group)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Gross Motor Function Measure-88 (GMFM-88)
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.
Time frame
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month2
Edinburgh Visual Gait Score (EVGS)
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.
Time frame
4 TIMES: preoperative; postoperative 3. month; 6. month; 12. monthLocations
Sponsors and contacts
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Elcin Akyurek
Lead sponsor
Istanbul University - Cerrahpasa
Sponsor institution
Source ClinicalTrials.gov
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