Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07810478

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

### Detailed Intervention Prescription

Participants allocated to the intervention group will receive a structured criteria-based progressive loading and functional rehabilitation program for approximately 6-8 weeks, consisting of 2-3 supervised physiotherapy sessions per week in addition to an individualized home exercise program. Each supervised session will last approximately 45-60 minutes and will include an individualized combination of joint mobility, muscle strengthening, balance, gait, and functional training according to the participant's clinical status and stage of recovery.

The fundamental principle of the intervention is that progression will be determined by predefined clinical and functional criteria rather than postoperative time alone. All weight-bearing and loading activities will strictly follow the restrictions prescribed by the treating orthopedic or surgical team. The physiotherapist will not independently advance a participant beyond the medically permitted weight-bearing level.

**Phase 1: Protection and Early Mobility**

During the initial phase, rehabilitation will focus on protecting the surgical site, controlling symptoms, maintaining joint mobility, minimizing muscle weakness, and achieving safe basic mobility. Treatment will include patient education, appropriate positioning, pain and edema management, active or active-assisted knee and ankle range-of-motion exercises as clinically permitted, quadriceps activation, hamstring and gluteal exercises, ankle exercises, and straight-leg raising when appropriate. Muscle activation and mobility exercises will generally be performed for 2-3 sets of 10-15 repetitions according to the participant's tolerance.

Functional rehabilitation during this phase will include bed mobility, transfer training, sit-to-stand practice when appropriate, and instruction in the safe use of crutches or a walker according to the prescribed weight-bearing status. Participants will also receive an individualized home exercise program focusing primarily on mobility and muscle activation.

Progression from this phase will not occur simply because a predetermined number of postoperative weeks has elapsed. Progression will be considered when the participant demonstrates satisfactory wound and soft-tissue status, controlled pain and swelling, improving knee and ankle mobility, safe transfers, appropriate performance of the prescribed exercises, and adequate neuromuscular control.

**Phase 2: Initial Loading and Gait Rehabilitation**

This phase will begin once increased loading or weight-bearing has been medically permitted by the orthopedic or surgical team. Treatment will focus on gradually introducing the permitted load to the affected limb and restoring safe functional mobility.

Interventions will include controlled weight-shifting activities, weight-bearing practice within the prescribed limits, gait retraining using the appropriate walking aid, progressive lower-limb strengthening, sit-to-stand training, supported balance exercises, continued knee and ankle mobility exercises, and progressive walking practice. Strengthening exercises will generally be performed for 2-3 sets of approximately 8-15 repetitions, with resistance adjusted according to the participant's clinical status and ability to perform the movement with appropriate control.

Gait training will emphasize safe loading of the affected limb within the prescribed restriction, appropriate step pattern, correct use of the walking aid, balance, and progressive improvement in walking quality. Walking duration and distance will be increased gradually according to tolerance.

Progression will be considered when the participant can tolerate the currently prescribed loading level without clinically significant worsening of pain, swelling, or other symptoms; demonstrate controlled weight transfer; perform functional activities with satisfactory movement control; and walk safely using the prescribed assistive device. Advancement to a higher weight-bearing level will occur only when permitted by the treating orthopedic team.

**Phase 3: Progressive Functional Loading**

As greater weight-bearing is medically permitted, rehabilitation will progressively emphasize functional loading, lower-limb strength, balance, gait quality, and independence. Treatment will include progressive closed-chain exercises, functional strengthening, repeated sit-to-stand practice, step-up and step-down activities, balance and proprioceptive exercises, progressive walking, and gait-quality training.

Exercises will generally be prescribed for approximately 2-4 sets of 8-15 repetitions depending on the exercise, participant tolerance, and functional goal. The difficulty of exercises will be progressively increased by modifying resistance, repetitions, movement complexity, balance demands, walking distance, or the amount of upper-limb support rather than progressing according to time alone.

Reliance on crutches, a walker, or other upper-limb support will be reduced gradually when clinically appropriate and when consistent with the prescribed weight-bearing status. The participant must demonstrate adequate balance and safe gait before progressing to a less supportive walking aid.

Progression to advanced functional rehabilitation will require satisfactory tolerance of the current loading level, controlled symptoms, adequate movement quality, improving functional mobility and balance, safe ambulation, and medical permission for further loading.

**Phase 4: Advanced Functional Rehabilitation**

Once full weight-bearing is medically permitted, rehabilitation will focus on restoring independent mobility and preparing the participant for community, daily living, and occupational activities. Treatment will include independent gait training, stair negotiation, uneven-surface walking, functional squatting, advanced balance and proprioceptive exercises, progressive lower-limb strengthening, walking endurance training, community mobility activities, and activities of daily living.

Where relevant, rehabilitation will also include work-, household-, or activity-specific tasks based on the participant's individual functional requirements. Walking duration and distance will be progressively increased, and the participant will be encouraged to achieve safe mobility with the least restrictive walking aid or without an assistive device when appropriate.

Throughout all phases, the physiotherapist will assess pain, swelling, range of motion, functional performance, gait safety, exercise tolerance, and any adverse clinical response. Exercise intensity or loading will be reduced or temporarily withheld if the participant develops clinically significant worsening of pain or swelling, wound problems, loss of functional performance, or other signs requiring medical reassessment. Suspected fixation-related complications, wound complications, or other significant adverse events will be referred to the treating medical or surgical team.

The home exercise program will be individualized according to the participant's current rehabilitation phase. Mobility and muscle-activation exercises may be performed daily, while strengthening, balance, gait, and functional activities will be prescribed according to clinical tolerance and safety. Adherence to the home program and supervised physiotherapy sessions will be documented.

The main distinction between this intervention and usual physiotherapy is therefore not the individual exercises themselves. Participants receiving usual physiotherapy may also receive range-of-motion exercises, strengthening, gait training, balance exercises, walking-aid training, and functional exercises. In the intervention group, however, rehabilitation will follow a standardized criteria-based pathway in which advancement, regression, and functional progression are determined by predefined clinical and functional milestones while remaining within the weight-bearing restrictions established by the orthopedic team.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Lower Extremity Functional Scale

    Time frame: pre, 12 weeks post and 3 months follow up

    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.

  2. Timed Up and Go Test (TUG)

    Time frame: pre, 12 weeks post and 3 months follow up

    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

  3. Numeric Pain Rating Scale (NPRS)

    Time frame: pre, 12 weeks post and 3 months follow up

    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 protoco

  4. Functional Ambulation Category

    Time frame: pre, 12 weeks post and 3 months follow up

    he 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

Secondary outcomes

  1. ROM

    Time frame: pre, 12 weeks post and 3 months follow up

    Measure ROM

  2. Walking-Aid Dependence

    Time frame: pre, 12 weeks post and 3 months follow up

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mosab M Aldabbas, PhD

CONTACT

[email protected]

00972597451222

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.