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
108 weeks
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
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.
CONDITIONS
Official 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, including 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 plans to rehabilitate at home
You will not qualify if you...
- Short expected survival from malignant diseases
- Muscle strength less than grade 3 with severe muscle atrophy in both lower limbs
- Having other neurological diseases
- Planned surgeries within the next 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
Trial Site Locations
Total: 1 location
1
Intelligent Powered Exoskeleton
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
W
Wanru Duan
CONTACT
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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