Using intelligent powered exoskeletons for rehabilitation after spinal surgery
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
This study is testing whether a smart powered exoskeleton can help people recover better from lower limb problems after spinal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06097000 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an intelligent powered exoskeleton designed to assist patients with lower limb motor dysfunction following spinal surgery. It aims to provide systematic rehabilitation training to improve recovery outcomes for patients who may not have access to specialized rehabilitation facilities. The study is a single-center, prospective, randomized controlled trial comparing recovery levels in patients using different rehabilitation strategies. Participants will be monitored for their progress in lower limb motor function as they undergo rehabilitation with the exoskeleton.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 who have undergone spinal surgery within the past year and are experiencing postoperative motor disorders in both lower limbs.
Not a fit: Patients with severe muscle atrophy or other neurological diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance rehabilitation outcomes for patients recovering from spinal surgery.
How similar studies have performed: Other studies have shown promise in using powered exoskeletons for rehabilitation, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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;
Where this trial is running
Beijing, Beijing Municipality
- Intelligent Powered Exoskeleton — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wanru Duan
- Email: duanwanru@xwhosp.org
- Phone: 13581803400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.