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

Capital Medical University

Status: Unknown

Conditions: Chronic Paraplegia

Treatments: Device: Training with traditional physiotherapy protocol; Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT03992690

XW-[2019]-023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

WANR protocol

Experimental group

Description:

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

Treatment:

Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol

Classical physiotherapy protocol

Active Comparator group

Description:

Training with classical physiotherapy protocol

Treatment:

Device: Training with traditional physiotherapy protocol