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

Primary Purpose

Chronic Paraplegia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol
Training with traditional physiotherapy protocol
Sponsored by
Xuanwu Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Paraplegia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xuanwu hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WANR protocol

Classical physiotherapy protocol

Arm Description

Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion

Training with classical physiotherapy protocol

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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).
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
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

Full Information

First Posted
June 18, 2019
Last Updated
July 30, 2019
Sponsor
Xuanwu Hospital, Beijing
Collaborators
the Alberto Santos Dumont Association for Research Support
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1. Study Identification

Unique Protocol Identification Number
NCT03992690
Brief Title
Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
Official Title
Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
Collaborators
the Alberto Santos Dumont Association for Research Support

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Paraplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WANR protocol
Arm Type
Experimental
Arm Description
Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion
Arm Title
Classical physiotherapy protocol
Arm Type
Active Comparator
Arm Description
Training with classical physiotherapy protocol
Intervention Type
Device
Intervention Name(s)
Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Training with traditional physiotherapy protocol
Intervention Description
Stretching
Primary Outcome Measure Information:
Title
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
Description
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)
Time Frame
After nine-months of training
Secondary Outcome Measure Information:
Title
The change of nociception improvement: ASIA pin-prick sensory score
Description
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
Time Frame
After nine-months of training
Title
Improvement of Walking index for SCI (WISCI)
Description
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).
Time Frame
After nine-months of training
Title
Change of WHO-QoL bref
Description
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
Time Frame
After nine-months of training
Title
Change of post-void residual urine
Description
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
Time Frame
After nine-months of training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng-Hu Wei, M.D.
Phone
00861083198252
Email
weipenghu@xwhosp.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guo-Guang Zhao, M.D.
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng-Hu Wei, M.D.
Phone
010-83198899
Ext
010-83198836
Email
weipenghu@xwhosp.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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