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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Intelligent Powered Exoskeleton
RECRUITING
Beijing
Contact Information
Primary
Wanru Duan
duanwanru@xwhosp.org
13581803400
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2025-11-20
Participants
Target number of participants: 80
Treatments
Experimental: Powered Exoskeleton Group
Rehabilitation exercises with powered exoskeletons
No_intervention: Traditional Group
Rehabilitation exercises without the use of powered exoskeletons
Sponsors
Collaborators: Beijing Haidian Hospital, BEIJING DNSYS INNOVATION Co. Ltd
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov