Clinical trial NCT06097000: A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Official title: A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exoskeleton Device
Keywords: Hip Exoskeleton Device
Spinal Cord Injuries
Rehabilitation
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: BEIJING DNSYS INNOVATION Co. Ltd
name: Beijing Haidian Hospital
First posted: 2023-10-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Six-minute walk test
timeFrame: 3 months
Secondary outcomes:
measure: Average rate of change in muscle strength
timeFrame: 3 months
measure: 10 meter autonomous walking test
timeFrame: 3 months
measure: 10 meter fast walking test
timeFrame: 3 months
measure: rate of change in hip joint mobility
timeFrame: 3 months
measure: stride length
timeFrame: 3 months
measure: rate of change in heart rate
timeFrame: 3 months
measure: rate of change in arterial partial pressure of oxygen
timeFrame: 3 months
measure: adverse event incidence rate
timeFrame: 12 months
measure: serious adverse event incidence rate
timeFrame: 12 months
measure: Thigh Swing Speed
timeFrame: 3 months
measure: Thigh Lifting Moment
timeFrame: 3 months
measure: Thigh Swing Angle
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Intelligent Powered Exoskeleton
state: Beijing
Study officials:
References: