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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Whether to use powered exoskeletons for exercise rehabilitation
Intelligent Powered Exoskeleton
Beijing, Beijing Municipality, China
RECRUITINGSix-minute walk test
meter; distance participants walked as fast as possible in a flat corridor in six minutes
Time frame: 3 months
Average rate of change in muscle strength
(change in muscle strength level\* number of persons)/total number of persons enrolled in the group
Time frame: 3 months
10 meter autonomous walking test
meter; participants walk ten meters at a self-selected speed
Time frame: 3 months
10 meter fast walking test
meter; participants walk ten meters at fastest speed
Time frame: 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
Time frame: 3 months
stride length
centimeter; left and right legs are measured separately
Time frame: 3 months
rate of change in heart rate
(post-training heart rate - resting heart rate)/resting heart rate
Time frame: 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
Time frame: 3 months
adverse event incidence rate
Number of cases of adverse events/number of enrollees
Time frame: 12 months
serious adverse event incidence rate
Number of cases of serious adverse events/number of enrollees
Time frame: 12 months
Thigh Swing Speed
degrees/second; left and right legs are measured separately
Time frame: 3 months
Thigh Lifting Moment
Newton\*Meter; left and right legs are measured separately
Time frame: 3 months
Thigh Swing Angle
degree; left and right legs are measured separately
Time frame: 3 months
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