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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Exoskeleton Device

Intervention / Treatment
-----------------
* Device: powered exoskeletons


Participation Criteria
=================
Eligibility 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powered Exoskeleton Group<br>Rehabilitation exercises with powered exoskeletons | Device: powered exoskeletons<br>* Whether to use powered exoskeletons for exercise rehabilitation<br>|
| No Intervention: Traditional Group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Exoskeleton Device, Spinal Cord Injuries, Rehabilitation