Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exoskeleton, Conventional rehabilitation program.
- Who it may be relevant to
- Registry conditions: Hip Fracture, Geriatrics, Lower Extremity Dysfunction, Postoperative Rehabilitation. Basic parameters: 65 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device 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 - Other 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
Primary outcome measures
- Harris Hip Score [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).]
Secondary outcome measures (7)
- Berg Balance Scale [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2)]
- Timed Up and Go Test [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).]
- 6-Minute Walk Test [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).]
- Visual Analogue Scale (VAS) [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).]
- Range of Motion Measurement [Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).]
- Psychological Assessment [Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).]
- Proteomics Analysis [Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
China · 1 center
- Beijing Jishuitan Hospital, Capital Medical University — Beijing
Identifiers
NCT: NCT07323147 · JST-IIT-2025086