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Clinical Trials in China / NCT06097000
Recruiting Not applicable

A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation

NCT06097000 · tracked via the Priya Life Science China tracker
Sponsor
Xuanwu Hospital, Beijing
Phase
Not applicable
Started
2023-10-20
Last updated
2025-07-11

Condition(s) studied

Exoskeleton Device

Investigational drug(s) / intervention(s)

powered exoskeletons

powered exoskeletons: Whether to use powered exoskeletons for exercise rehabilitation

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Intelligent Powered Exoskeleton Beijing Beijing Municipality Recruiting

More Xuanwu Hospital, Beijing trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06097000 on ClinicalTrials.gov ↗ ← All trials in China