Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

May 14, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Gastro Tenotomy
All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Other: Exercise
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Active Comparator: 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.
Procedure: Gastro Tenotomy
All participants meeting the inclusion criteria will undergo gastrotenotomy performed by a pediatric orthopedic surgeon.
Other: Exercise
Both groups will begin a physiotherapist-supervised physical therapy and rehabilitation program twice weekly for 12 weeks postoperatively.
Device: 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.
Other Names:
  • early intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elcin Akyurek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

May 14, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkyurekE5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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