Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Exoskeleton
  1. Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed duration. 2. Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range. 3. Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient active
• Другое Conventional rehabilitation program
  1. Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises; 2. Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadric

Первичные конечные точки

• Harris Hip Score [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2).]

Вторичные конечные точки (7)

• Berg Balance Scale [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2)]
• Timed Up and Go Test [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2).]
• 6-Minute Walk Test [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2).]
• Visual Analogue Scale (VAS) [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2).]
• Range of Motion Measurement [Срок оценки: 1-month post-intervention (T1), 3-month post-intervention (T2).]
• Psychological Assessment [Срок оценки: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).]
• Proteomics Analysis [Срок оценки: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Китай · 1 центр

• Beijing Jishuitan Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07323147 · JST-IIT-2025086

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗