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

NCT07810478 | Recruiting DMC

• 1 other identifier: Al-Azhar
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Tibial Fracture

Keywords

tibial fractures; Criteria-based rehabilitation; Progressive loading; Weight-bearing; Functional rehabilitation; Functional recovery

Outcome Measures

Primary Outcomes (4)

• 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.

  pre, 12 weeks post and 3 months follow up

• 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

  pre, 12 weeks post and 3 months follow up

• 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

  pre, 12 weeks post and 3 months follow up

• 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

  pre, 12 weeks post and 3 months follow up

Secondary Outcomes (2)

• ROM

  pre, 12 weeks post and 3 months follow up

• Walking-Aid Dependence

  pre, 12 weeks post and 3 months follow up

Study Arms (2)

Criteria-Based Progressive Loading and Functional Rehabilitation

EXPERIMENTAL

Participants assigned to the experimental arm will receive a structured criteria-based progressive loading and functional rehabilitation program for approximately 6-8 weeks, with 2-3 supervised physiotherapy sessions per week in addition to an individualized home exercise program. The program will progress through four rehabilitation phases according to predefined clinical and functional criteria rather than postoperative time alone. Phase 1 will focus on protection and early mobility and may include pain and edema management, positioning, knee and ankle range-of-motion exercises, quadriceps activation, hamstring and gluteal exercises, ankle exercises, bed mobility, transfer training, and safe use of walking aids. Phase 2 will introduce medically permitted loading through controlled weight shifting, weight-bearing practice, gait retraining, progressive strengthening, sit-to-stand training, supported balance exercises, and progressive walking. Phase 3 will emphasize progressive functi

Other: Criteria-Based Progressive Loading and Functional Rehabilitation Program

Usual Physiotherapy

ACTIVE COMPARATOR

Participants assigned to the control arm will receive the usual physiotherapy rehabilitation routinely provided at the participating rehabilitation centers following surgical fixation of traumatic tibial fractures. Usual physiotherapy may include pain and edema management, knee and ankle range-of-motion exercises, muscle strengthening, gait training, balance exercises, walking-aid training, functional exercises, progressive walking, and home exercise advice according to routine clinical practice and the individual needs of the participant. Weight-bearing and loading will follow the instructions provided by the treating orthopedic or surgical team. Unlike the experimental arm, progression of rehabilitation will not be guided by the standardized study-specific criteria-based progression algorithm. The number and duration of physiotherapy sessions and the principal interventions received will be documented throughout the study.

Other: Criteria-Based Progressive Loading and Functional Rehabilitation Program

Interventions

Criteria-Based Progressive Loading and Functional Rehabilitation Program OTHER

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

Criteria-Based Progressive Loading and Functional Rehabilitation; Usual Physiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mohammed Matar

Gaza, Gaza Strip, Palestinian Territories

RECRUITING

Related Publications (1)

• Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.

  PMID: 10201543 BACKGROUND

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Central Study Contacts

Mosab M Aldabbas, PhD

CONTACT

00972597451222; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor at Alazhar university, Gaza, Palestine

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 9, 2026
• Study Start: September 18, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09

Locations

PA (1)