Actively Recruiting
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Led by Xuanwu Hospital, Beijing · Updated on 2025-07-11
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
X
Xuanwu Hospital, Beijing
Lead Sponsor
B
BEIJING DNSYS INNOVATION Co. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of an intelligent powered exoskeleton designed to help patients regain lower limb function after spinal surgery. The study focuses on patients who have motor disorders in both legs following surgery for conditions like degeneration, tumor, or trauma. The goal is to compare different rehabilitation approaches and provide data to support future clinical studies. Participants are randomly assigned to one of two groups: one group will perform rehabilitation exercises using the powered exoskeleton device, while the other group will undergo traditional rehabilitation exercises without the exoskeleton. The study is conducted at a single center and follows patients for up to 12 months to assess various outcomes. During the study, participants will undergo several tests and measurements at 3 months, including a six-minute walk test, muscle strength evaluation, walking speed tests, hip joint mobility, stride length, heart rate changes, and oxygen levels. Safety is monitored through the recording of adverse events over 12 months. This comprehensive monitoring helps researchers understand how well the exoskeleton supports recovery and its safety profile over time.
CONDITIONS
Brief Title
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, or gait incoordination caused by deep sensory loss
- No plan to rehabilitate in a specialized rehabilitation hospital and intend to rehabilitate at home
You will not qualify if you...
- Short expected survival from malignant diseases
- Muscle strength less than grade 3 with severe atrophy in muscles of both lower limbs
- Presence of other neurological diseases
- Planned surgeries within 3 months
- Unable to cooperate with the powered exoskeleton or rehabilitation training due to physical condition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants use powered exoskeletons or perform traditional rehabilitation exercises to support postoperative spinal rehabilitation.
Duration - up to 12 months
Participants are monitored for safety and adverse events following the rehabilitation period.
Trial Site Locations
Total: 1 location
1
Intelligent Powered Exoskeleton
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Wanru Duan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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