Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture: A Multicenter, Open-Label, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Harris Hip Score
研究概览
简要总结
With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65 years or older, regardless of gender.
- •Diagnosed with a unilateral hip fracture resulting from low-energy trauma by imaging (X-ray/CT), and having undergone surgical treatment (internal fixation or arthroplasty).
- •The participant or their legal guardian understands and agrees to participate in the clinical trial and is willing to provide voluntary written informed consent.
排除标准
- •Life expectancy of less than 6 months.
- •History of neurological disorders such as prior stroke, spinal cord injury, Parkinson's disease, or myasthenia gravis.
- •Severe joint contractures, deformities, or heterotopic ossification in the lower limbs that would prevent proper device fitting.
- •Body weight exceeding the device's maximum load capacity (>100 kg).
- •Height outside the adjustable range of the device.
- •Presence of a pathological fracture or multiple fragility fractures.
- •Presence of severe osteoarthritis or trauma in the contralateral lower limb that significantly impairs function.
- •Comorbidities including active malignancy or systemic infection.
- •Comorbidities such as thromboembolic disease in the lower limbs, pneumonia, or pressure injuries (bedsores).
- •Comorbidities affecting rehabilitation capacity, including unstable angina, heart failure, severe sequelae of stroke, severe chronic obstructive pulmonary disease (COPD), or severe hepatic/renal dysfunction.
- •Poor compliance, cognitive impairment preventing cooperation, or diagnosed psychiatric disorders such as depression or anxiety.
- •Participation in any other clinical trial within the 3 months prior to screening.
研究组 & 干预措施
Intervention Group
Training with exoskeleton+Conventional rehabilitation program
干预措施: Exoskeleton (Device)
Control Group
Conventional rehabilitation program
干预措施: Conventional rehabilitation program (Other)
结局指标
主要结局
Harris Hip Score
时间窗: 1-month post-intervention (T1), 3-month post-intervention (T2).
Assessed using the Harris Hip Score (HHS), a disease-specific instrument widely used for evaluating outcomes following hip surgery or in hip pathology. The scale assesses the patient across four domains: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). The total score ranges from 0 to 100 points. A higher score indicates better hip joint function and less disability. The reported value is the total HHS score (points).
次要结局
- Berg Balance Scale(1-month post-intervention (T1), 3-month post-intervention (T2))
- Timed Up and Go Test(1-month post-intervention (T1), 3-month post-intervention (T2).)
- 6-Minute Walk Test(1-month post-intervention (T1), 3-month post-intervention (T2).)
- Visual Analogue Scale (VAS)(1-month post-intervention (T1), 3-month post-intervention (T2).)
- Range of Motion Measurement(1-month post-intervention (T1), 3-month post-intervention (T2).)
- Psychological Assessment(Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).)
- Proteomics Analysis(Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).)
研究者
Hai bao
Attending Physician
Beijing Jishuitan Hospital