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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Exoskeleton Device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Powered Exoskeleton Group

Rehabilitation exercises with powered exoskeletons

Group Type EXPERIMENTAL

powered exoskeletons

Intervention Type DEVICE

Whether to use powered exoskeletons for exercise rehabilitation

Traditional Group

Rehabilitation exercises without the use of powered exoskeletons

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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powered exoskeletons

Whether to use powered exoskeletons for exercise rehabilitation

Intervention Type DEVICE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No