Criteria-Based Rehabilitation After Tibial Fracture Fixation: A Randomized Controlled Trial
ConditionTibial Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAl-Azhar University
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Criteria-Based Progressive Loading and Functional Rehabilitation Program
Other interventionParticipants 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Criteria-Based Progressive Loading and Functional RehabilitationExperimental treatment 1 intervention
Group B: Usual PhysiotherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Lower Extremity Functional Scale
The LEFS will be used to assess lower-limb functional status and the participant's difficulty performing everyday activities. The scale consists of 20 items, each scored from 0 to 4, producing a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function. The primary endpoint will be the between-group difference in change in LEFS from baseline to completion of the intervention.
Time frame
pre, 12 weeks post and 3 months follow up2
Timed Up and Go Test (TUG)
Functional mobility will be assessed using the TUG. Participants will stand from a chair, walk 3 meters, turn, walk back to the chair, and sit down. The total time required to complete the task will be recorded in seconds, with a shorter time indicating better functional mobility. The test will only be performed when medically appropriate according to the participant's weight-bearing status
Time frame
pre, 12 weeks post and 3 months follow up3
Numeric Pain Rating Scale (NPRS)
Pain intensity will be measured using an 11-point numeric rating scale from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Lower scores indicate less pain. Pain at rest and/or during functional activity will be documented according to the study assessment protocol
Time frame
pre, 12 weeks post and 3 months follow up4
Functional Ambulation Category
The FAC will be used to classify the participant's level of functional walking independence and the amount of physical assistance required during ambulation. It is an ordinal scale ranging from 0 to 5, where 0 indicates inability to walk or the need for assistance from two or more people and 5 indicates independent ambulation. Higher scores indicate greater walking independence
Time frame
pre, 12 weeks post and 3 months follow upSecondary outcomes
1
ROM
ROM will be measured
Time frame
pre, 12 weeks post and 3 months follow up2
Walking-Aid Dependence
The type of assistive device required for walking will be recorded at each assessment. Categories will include walker, two crutches, one crutch, cane, or no walking aid. Changes toward a less supportive device or independent walking will be used as a clinically meaningful indicator of functional recovery
Time frame
pre, 12 weeks post and 3 months follow upSponsors and contacts
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Source ClinicalTrials.gov