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

Sponsor: Al-Azhar University • ClinicalTrials.gov ID: NCT07810478

Registry updated: 2026-09-21

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Description

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.

Interventions

Criteria-Based Progressive Loading and Functional Rehabilitation Program (Other)
Participants will receive a structured Criteria-Based Progressive Loading and Functional Rehabilitation Program for 12 weeks, consisting of 2-3 supervised physiotherapy sessions per week plus an individualized home exercise program. Rehabilitation will progress through four phases: protection and early mobility; initial loading and gait rehabilitation; progressive functional loading; and advanced functional rehabilitation. Treatment will include pain and edema management, knee and ankle range-of-motion exercises, progressive lower-limb strengthening, weight-shifting and permitted weight-bearing practice, gait training, balance and proprioceptive exercises, sit-to-stand and step training, progressive walking, endurance training, and functional mobility activities. Progression will be based on predefined clinical and functional criteria rather than time alone and will remain within orthopedic weight-bearing restrictions. Participants will be followed for an additional 3 months after comp

Eligibility criteria

Inclusion criteria: * Age ≥18 years. * Traumatic unilateral tibial fracture involving the proximal tibia/tibial plateau, tibial shaft, or distal tibia. * Treated with surgical fixation. * Recruitment 2-8 weeks after the index fixation surgery. * Medically and surgically stable and cleared by the treating team to participate in physiotherapy. * Documented postoperative weight-bearing status/instructions from the treating orthopedic team. * Able to participate in the study rehabilitation and complete the planned functional assessments when permitted by weight-bearing status. * Able to understand study instructions and provide written informed consent. * Open fractures are eligible provided the wound is clinically stable, there is no active uncontrolled infection preventing rehabilitation, and rehabilitation has been authorized by the treating surgical team. Exclusion criteria: * Pathological fracture. * Unstable fixation, fixation failure, or any orthopedic/medical contraindication to progressive rehabilitation. * Active or uncontrolled infection requiring restriction or interruption of rehabilitation. * Lower-limb amputation affecting functional assessment. * Spinal cord injury or severe traumatic brain injury affecting mobility or ability to participate. * Pre-existing neurological disorder substantially affecting gait or lower-limb function. * Major concomitant injury to either lower limb that substantially limits walking or participation in the rehabilitation protocol. * Severe cognitive impairment preventing understanding of instructions, valid outcome assessment, or informed consent. * Any medical condition considered by the treating physician to make participation in the rehabilitation program unsafe.

Conditions

Tibial Fracture

Locations

Mohammed Matar — Gaza, Gaza Strip, Palestinian Territories

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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