Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
NCT ID: NCT03992690
Last Updated: 2019-08-02
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-08-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol
Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
Classical physiotherapy protocol
Training with classical physiotherapy protocol
Training with traditional physiotherapy protocol
Stretching
Interventions
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Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol
Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
Training with traditional physiotherapy protocol
Stretching
Eligibility Criteria
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Inclusion Criteria
* 2\. Traumatic etiology;
* 3\. American Spinal Injury Association Impairment Scale(ASIA) A grade;
* 4\. The level of SCI in T9-T12;
* 5\. ≥12 months post injury;
* 6\. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
* 7\. Emotional stability;
Exclusion Criteria
* 2\. SCI non-traumatic etiology;
* 3\. Age\<18 years or Age\>60 years;
* 4\. Emotional instability;
* 5\. Unavailable time to join the protocol activities;
* 6\. Already enrolled in other research protocol;
* 7\. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
* 8\. Alcohol/drugs abuse and dependence;
* 9\. Psychiatric disorders (exception: treated depression);
* 10.Cognitive deficit; visual deficit; auditory deficit;
* 11\. Incapacitating pain;
* 12\. Pregnancy;
* 13\. Presence of limb amputations (exception: hand distal phalanges);
* 14\. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
* 15\. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
* 16\. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
* 17\. Movement disorders(e.g. ataxia);
* 18\. Use of medication that can negatively impact on neurological/motor recovery;
* 19\. Presence of joint deformities, presence of fractures;
* 20\. Lower limb spasticity MAS (Modified Ashworth Scale)\>2;
* 21\. Pressure ulcer: considering grade 3 or 4, injury size and body location;
* 22\. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
* 23\. Presence of cardiac or neural pacemaker;
* 24\. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
* 25\. Severe osteoporosis (Tscore\>-4);
* 26\. Syringomyelia;
* 27\. Lokomat or ZeroG training within the prior 3 months.
18 Years
60 Years
ALL
No
Sponsors
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the Alberto Santos Dumont Association for Research Support
UNKNOWN
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Principal Investigators
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Guo-Guang Zhao, M.D.
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Xuanwu hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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XW-[2019]-023
Identifier Type: -
Identifier Source: org_study_id
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