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

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

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.