4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia

Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia

Study Description
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.

Condition or disease Intervention/treatment Phase
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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
Experimental: WANR protocol
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
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.

Active Comparator: Classical physiotherapy protocol
Training with classical physiotherapy protocol
Device: Training with traditional physiotherapy protocol
Stretching

Outcome Measures
Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. The change of nociception improvement: ASIA pin-prick sensory score [ Time Frame: After nine-months of training ]

    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


  2. Improvement of Walking index for SCI (WISCI) [ Time Frame: After nine-months of training ]
    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).

  3. Change of WHO-QoL bref [ Time Frame: After nine-months of training ]
    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

  4. Change of post-void residual urine [ Time Frame: After nine-months of training ]
    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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Discomplete spinal cord injury;
  • 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:

  • 1. Absence of SCI, or presence of multi-segmental injury;
  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Peng-Hu Wei, M.D. 00861083198252 weipenghu@xwhosp.org

Locations
Layout table for location information
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   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
the Alberto Santos Dumont Association for Research Support
Investigators
Layout table for investigator information
Principal Investigator: Guo-Guang Zhao, M.D. Xuanwu Hospital, Beijing
Tracking Information
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
 (submitted: June 18, 2019)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • The change of nociception improvement: ASIA pin-prick sensory score [ Time Frame: After nine-months of training ]
    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
  • Improvement of Walking index for SCI (WISCI) [ Time Frame: After nine-months of training ]
    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).
  • Change of WHO-QoL bref [ Time Frame: After nine-months of training ]
    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
  • Change of post-void residual urine [ Time Frame: After nine-months of training ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • The change of nociception improvement: ASIA pin-prick sensory score [ Time Frame: After nine-months of training ]
    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
  • Improvement of Walking index for SCI (WISCI) [ Time Frame: After nine-months of training ]
    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).
  • Change of WHO-QoL bref [ Time Frame: After nine-months of training ]
    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
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
Condition  ICMJE Chronic Paraplegia
Intervention  ICMJE
  • 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.
  • Device: Training with traditional physiotherapy protocol
    Stretching
Study Arms  ICMJE
  • Experimental: WANR protocol
    Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
    Intervention: Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol
  • Active Comparator: Classical physiotherapy protocol
    Training with classical physiotherapy protocol
    Intervention: Device: Training with traditional physiotherapy protocol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
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:

  • 1. Discomplete spinal cord injury;
  • 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:

  • 1. Absence of SCI, or presence of multi-segmental injury;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Xuanwu Hospital, Beijing
Collaborators  ICMJE the Alberto Santos Dumont Association for Research Support
Investigators  ICMJE
Principal Investigator: Guo-Guang Zhao, M.D. Xuanwu Hospital, Beijing
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