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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Exoskeleton Device
• Intervention / Treatment: Device: powered exoskeletons

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wanru Duan; Phone Number: 13581803400; Email: duanwanru@xwhosp.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Powered Exoskeleton Group; Rehabilitation exercises with powered exoskeletons	Device: powered exoskeletons; Whether to use powered exoskeletons for exercise rehabilitation
No Intervention: Traditional Group; Rehabilitation exercises without the use of powered exoskeletons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test	meter; distance participants walked as fast as possible in a flat corridor in six minutes	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
10 meter autonomous walking test	meter; participants walk ten meters at a self-selected speed	3 months
10 meter fast walking test	meter; participants walk ten meters at fastest speed	3 months
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
stride length	centimeter; left and right legs are measured separately	3 months
rate of change in heart rate	(post-training heart rate - resting heart rate)/resting heart rate	3 months
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
adverse event incidence rate	Number of cases of adverse events/number of enrollees	12 months
serious adverse event incidence rate	Number of cases of serious adverse events/number of enrollees	12 months
Thigh Swing Speed	degrees/second; left and right legs are measured separately	3 months
Thigh Lifting Moment	Newton*Meter; left and right legs are measured separately	3 months
Thigh Swing Angle	degree; left and right legs are measured separately	3 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Beijing Haidian Hospital; BEIJING DNSYS INNOVATION Co. Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2023
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): November 20, 2025

Study Registration Dates

• First Submitted: September 27, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Spinal Cord Injuries; Hip Exoskeleton Device
• Other Study ID Numbers: XW-NS-IPEPSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No