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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Training with exoskeleton+Conventional rehabilitation program |
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| Control Group | Active Comparator | Conventional rehabilitation program |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exoskeleton | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | 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). | 1-month post-intervention (T1), 3-month post-intervention (T2). |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale | Assessed using the Berg Balance Scale. This scale consists of 14 items that evaluate static and dynamic balance abilities (e.g., standing, turning, picking up objects). Each item is scored from 0 to 4 points. The total score ranges from 0 to 56 points. A higher score indicates better balance function. The reported value is the total scale score (points). | 1-month post-intervention (T1), 3-month post-intervention (T2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Jishuitan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100035 | China |
Individual participant data (IPD) from this study will not be publicly shared due to ethical and privacy considerations, institutional data use agreements, and current resource limitations. Access may be reconsidered in compliance with future funder or publisher requirements. For inquiries, please contact the principal investigator.
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The target total sample size is 86 participants. A competitive enrollment model will be used, with no pre-set quota for individual study sites. All participating centers will collectively compete to achieve the overall recruitment target.
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| Conventional rehabilitation program | Other |
|
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| Timed Up and Go Test | The time required for the subject to rise from a chair, walk 3 meters, turn around, walk back, and sit down is recorded. The reported value is the time to complete the test (seconds). A shorter time indicates better functional mobility. | 1-month post-intervention (T1), 3-month post-intervention (T2). |
| 6-Minute Walk Test | The maximum distance a subject can walk on a flat surface within 6 minutes is measured. The reported value is the total walking distance (meters). A greater distance indicates better walking endurance. | 1-month post-intervention (T1), 3-month post-intervention (T2). |
| Visual Analogue Scale (VAS) | Assessed using the Visual Analogue Scale (VAS) to evaluate the subject's average pain intensity over the past 24 hours. Subjects mark their pain level on a 10-cm line anchored with "no pain" (0) and "worst pain imaginable" (10). The reported value is the distance from the start point to the mark (centimeters). A higher score indicates more severe pain. | 1-month post-intervention (T1), 3-month post-intervention (T2). |
| Range of Motion Measurement | The active range of flexion of the affected hip joint is measured using a universal goniometer. The reported value is the angle of flexion (degrees). A greater angle indicates better joint mobility function. | 1-month post-intervention (T1), 3-month post-intervention (T2). |
| Psychological Assessment | Assessed using the anxiety subscale (HADS-A) of the Hospital Anxiety and Depression Scale (HADS). This subscale comprises 7 items, each scored from 0 to 3 points. The total score ranges from 0 to 21 points. A higher score indicates more severe anxiety symptoms. The reported value is the total subscale score for anxiety (points). | Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2). |
| Proteomics Analysis | Proteomic analysis is performed on fasting venous blood samples to compare protein expression profiles between different time points (T1/T2 vs. T0) and between groups (intervention vs. control). The reported value is the number of statistically significant differentially expressed proteins identified under set significance thresholds (e.g., p<0.05 and fold change >1.5). | Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2). |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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