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| Name | Class |
|---|---|
| the Alberto Santos Dumont Association for Research Support | UNKNOWN |
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The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WANR protocol | Experimental | Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion |
|
| Classical physiotherapy protocol | Active Comparator | Training with classical physiotherapy protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point | The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side) | After nine-months of training |
| Measure | Description | Time Frame |
|---|---|---|
| The change of nociception improvement: ASIA pin-prick sensory score | Testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body that can be readily located in relation to bony anatomical landmarks. At each of these key points, sensation of pin prick is examined: Appreciation of pin prick sensation at each of the key points is separately scored on a three-point scale, with comparison to the sensation on the patients' cheek as a normal frame of reference: 0 = absent 1= altered (impaired or partial appreciation, including hyperesthesia) 2 = normal or intact (similar as on the cheek) NT = not testable The maximum scale is 112 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng-Hu Wei, M.D. | Contact | 00861083198252 | weipenghu@xwhosp.org |
| Name | Affiliation | Role |
|---|---|---|
| Guo-Guang Zhao, M.D. | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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|
| Training with traditional physiotherapy protocol | Device | Stretching |
|
| After nine-months of training |
| Improvement of Walking index for SCI (WISCI) | The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI). | After nine-months of training |
| Change of WHO-QoL bref | The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction that divided into four domains. Raw domain scores for the WHOQOL were transformed to a 4-20 score according to guidelines | After nine-months of training |
| Change of post-void residual urine | Usually, the value is less than 50 ml. A post-void residual urine greater than 50 ml is a significant amount of urine and increases the potential for recurring urinary tract infections. In adults older than 60 years, 50-100 ml of residual urine may remain after each voiding because of the decreased contractility of the detrusor muscle | After nine-months of training |
| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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