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NOT YET RECRUITING
NCT07810478
NA

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

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Effectiveness of a Criteria-Based Progressive Loading and Functional Rehabilitation Program Compared With Usual Physiotherapy Following Surgical Fixation of Traumatic Tibial Fractures: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-03

Completion Date

2027-07-01

Last Updated

2026-09-14

Healthy Volunteers

Yes

Conditions

Interventions

OTHER

Criteria-Based Progressive Loading and Functional Rehabilitation Program

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