A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Xuanwu Hospital, Beijing
80 participants
Oct 20, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria5
- 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;
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Whether to use powered exoskeletons for exercise rehabilitation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06097000