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

Capital Medical University

Status

Enrolling

Conditions

Exoskeleton Device

Treatments

Device: powered exoskeletons

Study type

Interventional

Funder types

Other

Identifiers

NCT06097000

XW-NS-IPEPSR

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;