Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

NCT07598604 | Not Yet Recruiting

• 1 other identifier: AkyurekE5
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cerebral Palsy

Keywords

cerebral palsy; gastrotenotomy; eqinus

Outcome Measures

Primary Outcomes (2)

• 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.

  4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month

• 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.

  4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month

Study Arms (2)

Group 1 (Cast Group)

ACTIVE COMPARATOR

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.

Procedure: Gastro Tenotomy; Other: Exercise

Group 2 (AFO Group)

ACTIVE COMPARATOR

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.

Procedure: Gastro Tenotomy; Device: ankle foot orthosis; Other: Exercise

Interventions

Gastro Tenotomy PROCEDURE

All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.

Group 1 (Cast Group); Group 2 (AFO Group)

ankle foot orthosis DEVICE

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.

Also known as: early intervention

Group 2 (AFO Group)

Exercise OTHER

Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.

Group 1 (Cast Group); Group 2 (AFO Group)

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elcin Akyurek: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist

Model Details: This study is a prospective, observational clinical investigation with long-term follow-up after the intervention

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share