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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

NCT ID NCT07810478

NEW Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tibial fracture

How to take part

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  1. The official record

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  2. A doctor treating you

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