Early Mobilization and Equinus Correction in Spastic Cerebral Palsy

Sponsor
Elcin Akyurek
Study ID
NCT07598604
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
4 Years - 14 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 20, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 30, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Gross Motor Function Measure-88 (GMFM-88) [ Time Frame: 4 TIMES: preoperative; postoperative 3. month; 6. month; 12. month ]

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