Condition or disease | Intervention/treatment | Phase |
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Chronic Paraplegia | Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol Device: Training with traditional physiotherapy protocol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia |
Estimated Study Start Date : | August 1, 2019 |
Estimated Primary Completion Date : | March 31, 2020 |
Estimated Study Completion Date : | December 31, 2020 |
Arm | Intervention/treatment |
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Experimental: WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
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Device: 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.
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Active Comparator: Classical physiotherapy protocol
Training with classical physiotherapy protocol
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Device: Training with traditional physiotherapy protocol
Stretching
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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
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peng-Hu Wei, M.D. | 00861083198252 | weipenghu@xwhosp.org |
China, Beijing | |
Xuanwu hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China, 100053 | |
Contact: Peng-Hu Wei, M.D. 010-83198899 ext 010-83198836 weipenghu@xwhosp.org |
Principal Investigator: | Guo-Guang Zhao, M.D. | Xuanwu Hospital, Beijing |
Tracking Information | |||||
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First Submitted Date ICMJE | June 18, 2019 | ||||
First Posted Date ICMJE | June 20, 2019 | ||||
Last Update Posted Date | August 2, 2019 | ||||
Estimated Study Start Date ICMJE | August 1, 2019 | ||||
Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point [ Time Frame: After nine-months of training ] 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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia | ||||
Official Title ICMJE | Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Paraplegia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Unknown status | ||||
Estimated Enrollment ICMJE |
40 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2020 | ||||
Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03992690 | ||||
Other Study ID Numbers ICMJE | XW-[2019]-023 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xuanwu Hospital, Beijing | ||||
Study Sponsor ICMJE | Xuanwu Hospital, Beijing | ||||
Collaborators ICMJE | the Alberto Santos Dumont Association for Research Support | ||||
Investigators ICMJE |
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PRS Account | Xuanwu Hospital, Beijing | ||||
Verification Date | June 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |