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

Exoskeleton Device Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06097000
• Other study ID #: XW-NS-IPEPSR
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: November 20, 2025

Study information

• Verified date: September 2023
• Source: Xuanwu Hospital, Beijing
• Contact: Wanru Duan
• Phone: 13581803400
• Email: duanwanru[@]xwhosp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Exoskeleton Device

Intervention

Device:
• powered exoskeletons
Whether to use powered exoskeletons for exercise rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	BEIJING DNSYS INNOVATION Co. Ltd, Beijing Haidian Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-minute walk test	meter; distance participants walked as fast as possible in a flat corridor in six minutes	3 months
Secondary	Average rate of change in muscle strength	(change in muscle strength level* number of persons)/total number of persons enrolled in the group	3 months
Secondary	10 meter autonomous walking test	meter; participants walk ten meters at a self-selected speed	3 months
Secondary	10 meter fast walking test	meter; participants walk ten meters at fastest speed	3 months
Secondary	rate of change in hip joint mobility	(hip joint mobility with assistance - hip joint mobility without assistance)/hip joint mobility without assistance; use joint mobility scales to measure hip joint mobility	3 months
Secondary	stride length	centimeter; left and right legs are measured separately	3 months
Secondary	rate of change in heart rate	(post-training heart rate - resting heart rate)/resting heart rate	3 months
Secondary	rate of change in arterial partial pressure of oxygen	(post-training arterial partial pressure of oxygen - arterial partial pressure of oxygen at rest)/arterial partial pressure of oxygen at rest	3 months
Secondary	adverse event incidence rate	Number of cases of adverse events/number of enrollees	12 months
Secondary	serious adverse event incidence rate	Number of cases of serious adverse events/number of enrollees	12 months
Secondary	Thigh Swing Speed	degrees/second; left and right legs are measured separately	3 months
Secondary	Thigh Lifting Moment	Newton*Meter; left and right legs are measured separately	3 months
Secondary	Thigh Swing Angle	degree; left and right legs are measured separately	3 months