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

Recruiting now · Not applicable

Conditions studied: Exoskeleton Device

In brief

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.

Key facts

Study ID

NCT06097000

Run by

Xuanwu Hospital, Beijing

People needed

80

Starts

2023-10-20

Expected to finish

2025-11-20

Last updated by the study team

2025-07-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Intelligent Powered Exoskeleton — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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