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| Name | Class |
|---|---|
| BEIJING DNSYS INNOVATION Co. Ltd | UNKNOWN |
| Beijing Haidian Hospital | OTHER |
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Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered Exoskeleton Group | Experimental | Rehabilitation exercises with powered exoskeletons |
|
| Traditional Group | No Intervention | Rehabilitation exercises without the use of powered exoskeletons |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| powered exoskeletons | Device | Whether to use powered exoskeletons for exercise rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Six-minute walk test | meter; distance participants walked as fast as possible in a flat corridor in six minutes | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Average rate of change in muscle strength | (change in muscle strength level* number of persons)/total number of persons enrolled in the group | 3 months |
| 10 meter autonomous walking test | meter; participants walk ten meters at a self-selected speed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wanru Duan | Contact | 13581803400 | duanwanru@xwhosp.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intelligent Powered Exoskeleton | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 3 months |
| 10 meter fast walking test | meter; participants walk ten meters at fastest speed | 3 months |
| rate of change in hip joint mobility | (hip joint mobility with assistance - hip joint mobility without assistance)/hip joint mobility without assistance; use joint mobility scales to measure hip joint mobility | 3 months |
| stride length | centimeter; left and right legs are measured separately | 3 months |
| rate of change in heart rate | (post-training heart rate - resting heart rate)/resting heart rate | 3 months |
| rate of change in arterial partial pressure of oxygen | (post-training arterial partial pressure of oxygen - arterial partial pressure of oxygen at rest)/arterial partial pressure of oxygen at rest | 3 months |
| adverse event incidence rate | Number of cases of adverse events/number of enrollees | 12 months |
| serious adverse event incidence rate | Number of cases of serious adverse events/number of enrollees | 12 months |
| Thigh Swing Speed | degrees/second; left and right legs are measured separately | 3 months |
| Thigh Lifting Moment | Newton*Meter; left and right legs are measured separately | 3 months |
| Thigh Swing Angle | degree; left and right legs are measured separately | 3 months |
| D014947 | Wounds and Injuries |