A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: powered exoskeletons.
- Who it may be relevant to
- Registry conditions: Exoskeleton Device. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device powered exoskeletons
Whether to use powered exoskeletons for exercise rehabilitation
Primary outcome measures
- Six-minute walk test [Time frame: 3 months]
Secondary outcome measures (12)
- Average rate of change in muscle strength [Time frame: 3 months]
- 10 meter autonomous walking test [Time frame: 3 months]
- 10 meter fast walking test [Time frame: 3 months]
- rate of change in hip joint mobility [Time frame: 3 months]
- stride length [Time frame: 3 months]
- rate of change in heart rate [Time frame: 3 months]
- rate of change in arterial partial pressure of oxygen [Time frame: 3 months]
- adverse event incidence rate [Time frame: 12 months]
- serious adverse event incidence rate [Time frame: 12 months]
- Thigh Swing Speed [Time frame: 3 months]
- Thigh Lifting Moment [Time frame: 3 months]
- Thigh Swing Angle [Time frame: 3 months]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Intelligent Powered Exoskeleton — Beijing
Identifiers
NCT: NCT06097000 · XW-NS-IPEPSR