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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Lower Extremity Functional Scale
研究概览
简要总结
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.
详细描述
### 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Usual Physiotherapy
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.
干预措施: Criteria-Based Progressive Loading and Functional Rehabilitation Program (Other)
Criteria-Based Progressive Loading and Functional Rehabilitation
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
干预措施: Criteria-Based Progressive Loading and Functional Rehabilitation Program (Other)
结局指标
主要结局
Lower Extremity Functional Scale
时间窗: 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.
Timed Up and Go Test (TUG)
时间窗: 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
Numeric Pain Rating Scale (NPRS)
时间窗: 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 protocol
Functional Ambulation Category
时间窗: pre, 12 weeks post and 3 months follow up
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
次要结局
- Walking-Aid Dependence(pre, 12 weeks post and 3 months follow up)
- ROM(pre, 12 weeks post and 3 months follow up)
研究者
Mosab ALdabbas
Assistant Professor at Alazhar university, Gaza, Palestine
Al-Azhar University