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Criteria-Based Rehabilitation After Tibial Fracture Fixation: A Randomized Controlled Trial

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Oct 3, 2026 to Sep 18, 2026
    • Study sites: 0 to 1
  2. Minor Eligibility criteria expanded, about 18 words
  3. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 2 entries
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This randomized controlled trial will evaluate the effectiveness of a criteria-based progressive loading and functional rehabilitation program compared with usual physiotherapy in adults following surgical fixation of traumatic tibial fractures in Gaza. Participants will be randomly allocated to either a structured 6-8-week rehabilitation program, in which progression is guided by predefined clinical and functional criteria while respecting orthopedic weight-bearing restrictions, or to usual physiotherapy. The primary outcome will be lower-limb function measured using the Lower Extremity Functional Scale (LEFS). Secondary outcomes will include functional mobility, walking endurance, pain, knee and ankle range of motion, functional ambulation, walking-aid dependence, and adverse events. Outcomes will be assessed at baseline, post-intervention, and follow-up. The study aims to determine whether a standardized criteria-based rehabilitation approach can improve functional recovery following traumatic tibial fracture fixation.
Trial Details
NCT Number NCT07810478
Lead Sponsor Al-Azhar University
Conditions
(from sponsor)
Tibial Fracture
Related terms Tibial Fractures
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov