Effect of Early Rehabilitation on Functional Recovery After Total Hip Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) Test
研究概览
简要总结
This study aims to investigate the effects of an early postoperative rehabilitation program combined with neuromuscular electrical stimulation (NMES) and telerehabilitation on functional recovery in patients undergoing total hip arthroplasty (THA).
In the early postoperative period, patients commonly experience muscle weakness, impaired gait, and functional limitations that may delay recovery. Early rehabilitation has been shown to improve functional outcomes, while NMES may enhance muscle activation, particularly in hip abductor muscles. Additionally, telerehabilitation may support continuity of care following discharge by enabling supervised home-based exercise.
In this prospective study, participants will be assigned to either an intervention group receiving early physiotherapy combined with NMES and telerehabilitation, or a control group receiving standard postoperative care. Functional outcomes, gait parameters, quality of life, and muscle-related changes will be evaluated at predefined time points.
详细描述
This study is designed as a prospective, randomized controlled clinical trial to evaluate the effectiveness of an early postoperative rehabilitation program combined with neuromuscular electrical stimulation (NMES) and telerehabilitation in patients undergoing total hip arthroplasty (THA).
Following THA, patients frequently experience muscle weakness, gait asymmetries, and reduced functional capacity, which may prolong recovery. Although early mobilization and rehabilitation are widely recommended, the combined effects of NMES and telerehabilitation within a structured early-phase rehabilitation program have not been sufficiently investigated.
Participants will be randomly allocated into intervention and control groups using a simple randomization method. The intervention group will receive a structured physiotherapy program initiated on the first postoperative day and continued daily during hospitalization. This program will be combined with NMES targeting the gluteus medius muscle, applied using surface electrodes placed over the motor point with stimulation parameters adjusted according to patient tolerance.
After discharge, participants in the intervention group will continue a structured home-based exercise program supported by synchronous telerehabilitation sessions conducted three times per week. These sessions will enable real-time supervision, feedback on exercise performance, and progression based on standardized tolerance criteria.
The control group will receive the standard postoperative care protocol routinely applied in the clinic, without additional NMES or telerehabilitation support.
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)
盲法说明
The study was designed as a single-blind randomized controlled trial in which outcome assessments were performed by an independent and experienced physiotherapist blinded to group allocation.
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral total hip arthroplasty due to osteoarthritis or developmental dysplasia of the hip (DDH)
- •Aged between 50 and 75 years
- •Willing and able to participate in all follow-up assessments
- •Able to comply with assessment procedures
- •Able to meet the requirements of telerehabilitation
- •Undergoing surgery with a standardized surgical protocol
排除标准
- •Previous history of total hip arthroplasty on either side
- •Planned revision total hip arthroplasty
- •Severe osteoarthritis in the contralateral hip
- •Presence of severe acute metabolic, neuromuscular, or cardiovascular disease
- •History of active malignancy
- •Presence of respiratory infection
- •Concomitant orthopedic conditions (e.g., lower extremity fractures, severe hip/knee deformities, lumbar or sacroiliac dysfunction)
- •Body mass index >35
- •Occurrence of postoperative complications (e.g., prosthetic infection, thromboembolic events, or conditions requiring reoperation)
研究组 & 干预措施
Experimental Group (Early Physiotherapy + NMES + Telerehabilitation)
Participants will receive a structured physiotherapy program initiated on the first postoperative day, including exercise and neuromuscular electrical stimulation (NMES) targeting the gluteus medius during hospitalization (5 days). After discharge, the intervention will continue with a 3-week home-based exercise program supported by synchronous telerehabilitation sessions conducted three times per week.
干预措施: Early Postoperative Physiotherapy (Other)
Experimental Group (Early Physiotherapy + NMES + Telerehabilitation)
Participants will receive a structured physiotherapy program initiated on the first postoperative day, including exercise and neuromuscular electrical stimulation (NMES) targeting the gluteus medius during hospitalization (5 days). After discharge, the intervention will continue with a 3-week home-based exercise program supported by synchronous telerehabilitation sessions conducted three times per week.
干预措施: Neuromuscular Electrical Stimulation (NMES) (Device)
Experimental Group (Early Physiotherapy + NMES + Telerehabilitation)
Participants will receive a structured physiotherapy program initiated on the first postoperative day, including exercise and neuromuscular electrical stimulation (NMES) targeting the gluteus medius during hospitalization (5 days). After discharge, the intervention will continue with a 3-week home-based exercise program supported by synchronous telerehabilitation sessions conducted three times per week.
干预措施: Telerehabilitation (Other)
Control Group (Standard Care)
Participants will receive the hospital's standard postoperative care during hospitalization, including routine monitoring and wound care without a structured physiotherapy program. At discharge, they will be provided with a home exercise brochure with instructions but will not receive supervised telerehabilitation.
干预措施: Standard Postoperative Care (Other)
结局指标
主要结局
Timed Up and Go (TUG) Test
时间窗: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4.
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds.
10-Meter Walk Test (10MWT)
时间窗: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4
Gait speed will be assessed using the 10-Meter Walk Test. Walking speed will be recorded in meters per second (m/s).
Stair Climb Test
时间窗: Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4
Functional lower extremity performance will be assessed using the Stair Climb Test. The time required to ascend and descend a standardized flight of stairs will be recorded in seconds.
次要结局
- 6-Minute Walk Test (6MWT)(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Hip Muscle Strength (Manual Muscle Testing)(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Range of Motion (ROM)(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Pain Intensity (Visual Analog Scale - VAS)(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Hip Function and Quality of Life (International Hip Outcome Tool-12)(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Gluteus Medius Muscle Sarcopenia (CT-Based Assessment)(Preoperative (within 3 days before surgery) and postoperative week 4)
- Step Length(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Cadence(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
- Walking Speed(Preoperative (within 3 days before surgery), postoperative day 6 (at discharge), and postoperative week 4)
研究者
Cansu DAL
Specialist Physiotherapist
Muğla Sıtkı Koçman University