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.
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;
Parallel
powered exoskeletons
DeviceWhether to use powered exoskeletons for exercise rehabilitation
Six-minute walk test
meter; distance participants walked as fast as possible in a flat corridor in six minutes
Average rate of change in muscle strength
(change in muscle strength level\* number of persons)/total number of persons enrolled in the group
10 meter autonomous walking test
meter; participants walk ten meters at a self-selected speed
10 meter fast walking test
meter; participants walk ten meters at fastest speed
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
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Xuanwu Hospital, Beijing
Lead sponsor
BEIJING DNSYS INNOVATION Co. Ltd
Collaborator
Beijing Haidian Hospital
Collaborator
