NCT07810478 Criteria-Based Rehabilitation After Tibial Fracture Fixation: A Randomized Controlled Trial
| NCT ID | NCT07810478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al-Azhar University |
| Condition | Tibial Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-09-18 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-09-18 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07810478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Tibial Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07810478 currently recruiting?
Yes, NCT07810478 is actively recruiting participants. Contact the research team at mosab.m.aldabbas@gmail.com for enrollment information.
Where is the NCT07810478 trial being conducted?
This trial is being conducted at Gaza, Palestinian Territories.
Who is sponsoring the NCT07810478 clinical trial?
NCT07810478 is sponsored by Al-Azhar University. The trial plans to enroll 120 participants.