A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
- Conditions
- Exoskeleton Device
- Interventions
- Device: powered exoskeletons
- Registration Number
- NCT06097000
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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;
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Powered Exoskeleton Group powered exoskeletons Rehabilitation exercises with powered exoskeletons
- Primary Outcome Measures
Name Time Method Six-minute walk test 3 months meter; distance participants walked as fast as possible in a flat corridor in six minutes
- Secondary Outcome Measures
Name Time Method Thigh Lifting Moment 3 months Newton\*Meter; left and right legs are measured separately
rate of change in hip joint mobility 3 months (hip joint mobility with assistance - hip joint mobility without assistance)/hip joint mobility without assistance; use joint mobility scales to measure hip joint mobility
stride length 3 months centimeter; left and right legs are measured separately
adverse event incidence rate 12 months Number of cases of adverse events/number of enrollees
10 meter autonomous walking test 3 months meter; participants walk ten meters at a self-selected speed
10 meter fast walking test 3 months meter; participants walk ten meters at fastest speed
Thigh Swing Angle 3 months degree; left and right legs are measured separately
Average rate of change in muscle strength 3 months (change in muscle strength level\* number of persons)/total number of persons enrolled in the group
rate of change in heart rate 3 months (post-training heart rate - resting heart rate)/resting heart rate
rate of change in arterial partial pressure of oxygen 3 months (post-training arterial partial pressure of oxygen - arterial partial pressure of oxygen at rest)/arterial partial pressure of oxygen at rest
serious adverse event incidence rate 12 months Number of cases of serious adverse events/number of enrollees
Thigh Swing Speed 3 months degrees/second; left and right legs are measured separately
Trial Locations
- Locations (1)
Intelligent Powered Exoskeleton
🇨🇳Beijing, Beijing, China