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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuanwu Hospital, Beijing

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • powered exoskeletons

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Xuanwu Hospital, Beijing

Lead sponsor

BEIJING DNSYS INNOVATION Co. Ltd

Collaborator

Beijing Haidian Hospital

Collaborator