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

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.

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.