Status:
RECRUITING
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
BEIJING DNSYS INNOVATION Co. Ltd
Beijing Haidian Hospital
Conditions:
Exoskeleton Device
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 re...
Eligibility Criteria
Inclusion
- Age 18-70 years old;
- Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
- The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;
Exclusion
- Short expected survival from malignant diseases;
- Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
- Suffering from other neurological diseases;
- Planned to undergo other surgeries within 3 months;
- Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06097000
Start Date
October 20 2023
End Date
November 20 2025
Last Update
July 11 2025
Active Locations (1)
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1
Intelligent Powered Exoskeleton
Beijing, Beijing Municipality, China