Objective: Comprehensive clinical neurological assessment of paraplegic patients with chronic spinal cord injury undergoing brain-machine interface neurorehabilitation training to evaluate changes in neurological status, physical function, and psychological well-being over 12 months
This is a Clinical Neurological Assessment protocol using human as the model organism. The procedure involves 19 procedural steps, 6 equipment items, 4 materials. Extracted from a 2016 paper published in Scientific Reports.
Model and subjects
human • N/A • unknown • Not specified • 50-80 kg (exoskeleton accommodation range) • 8
Study window
Estimated timing pending
Core workflow
Patient enrollment and informed consent • Baseline clinical evaluation (Day 0) • Component 1: Immersive virtual reality BMI training (seated)
Primary readouts
Key equipment and reagents
Verified items
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Eight paraplegic patients with chronic spinal cord injury (>1 year) were enrolled. All participants signed written informed consent before enrolling in the study. Ethics approval obtained from local ethics committee (Associação de Assistência à Criança Deficiente, Sao Paulo, Brazil #364.027) and Brazilian federal government ethics committee (CONEP, CAAE: 13165913.1.0000.0085).
Note: Seven patients had complete SCI, one had incomplete SCI
“Eight paraplegic patients, suffering from chronic (>1 year) spinal cord injury (SCI, seven complete and one incomplete)”
Comprehensive clinical evaluations performed on the first day patients began training. Evaluations include: ASIA Impairment Scale, Semmes-Weinstein Monofilament Test, temperature/vibration/proprioception/deep pressure sensitivity evaluation, muscle strength test (Lokomat L-force Evaluation), Thoracic-Lumbar Scale for trunk control, WISCI, SCIM, McGill Pain Questionnaire, Visual Analogue Scale for pain, range of motion assessment using Medical Research Council scale, Modified Ashworth Scale, Lokomat L-stiff Evaluation for spasticity, WHOQoL-Bref, Rosenberg Self-Esteem Scale, and Beck Depression Inventory.
Note: Routine general clinical evaluations also performed (cardiovascular function, intestinal/urinary emptying, skin inspection, spasticity handling)
“Such clinical evaluation started on the first day patients began training (Day 0)”
Seated patient employs brain activity recorded via 16-channel EEG to control movements of human body avatar in immersive virtual reality environment. Patient receives visuo-tactile feedback. Initially, patients imagine arm movements to modulate EEG activity for high-level motor commands ('walk' or 'stop'). After mastering this, patients learn to control individual avatar leg stepping by imagining leg movements. Confirmation of choice made by isometric triceps contraction. Virtual avatar simulated in MotionBuilder 2014 and visualized from first-person perspective using Oculus Rift headset.
Note: Tactile feedback provided via haptic display with vibrator arrays on forearms
“an immersive virtual reality environment in which a seated patient employed his/her brain activity, recorded via a 16-channel EEG, to control the movements of a human body avatar, while receiving visuo-tactile feedback”
Identical interaction with virtual environment and BMI protocol as Component 1, but with patient in upright position supported by stand-in-table device. Same EEG recording, avatar control, and tactile feedback mechanisms applied.
Note: Progression from seated to upright posture increases postural control demands
“identical interaction with the same virtual environment and BMI protocol while patients were upright, supported by a stand-in-table device”
Training on Lokomat robotic gait device (Hocoma AG, Switzerland) with integrated body weight support system and treadmill. No tactile feedback provided for this component.
Note: One of two components without continuous tactile feedback
“training on a robotic body weight support (BWS) gait system on a treadmill (Lokomat, Hocoma AG, Switzerland)”
Training with ZeroG body weight support gait system (Aretech LLC., Ashburn, VA) fixed on overground track. No mechanical barriers between patient and physical therapist. Requires patient to manage postural/trunk control, upper limb strength, and dynamic balance. No tactile feedback provided for this component.
Note: Overground setup offers more challenges than treadmill-based systems; no tactile feedback component
“training with a BWS gait system fixed on an overground track (ZeroG, Aretech LLC., Ashburn, VA)”
Training with brain-controlled robotic body weight support gait system on treadmill. EEG-based BMI control integrated with robotic gait training. Continuous tactile feedback provided via haptic display on forearms synchronized with robotic foot rolling.
Note: Combines BMI control with robotic gait training
“training with a brain-controlled robotic BWS gait system on a treadmill”
Gait training with brain-controlled, sensorized 12 degrees of freedom robotic exoskeleton. Custom-built device with autonomous power, self-stabilization, and full lower limb hydraulic actuation. Accommodates weight range of 50-80 kg without requiring crutches. Used in conjunction with ZeroG overground body weight support system. Continuous tactile feedback provided via haptic display on forearms synchronized with exoskeleton foot rolling.
Note: Most advanced component; overground setup with ZeroG system provides maximum challenge to postural control and balance
“gait training with a brain-controlled, sensorized 12 degrees of freedom robotic exoskeleton”
Training complexity increased over time to ensure cardiovascular stability and better postural control. Progression starts with orthostatic training at stand-in-table and advances through different gait training robotic systems.
Note: Gradual progression ensures patient safety and optimal adaptation
“complexity of activities was increased over time to ensure cardiovascular system stability and better patient postural control; starting with orthostatic training at a stand-in-table and progressing all the way to the different gait training robotic systems”
Further gait training performed using lower limb orthosis (hip-knee-ankle-foot orthosis or ankle-foot orthosis with knee extension splint) and wheeled triangular walker.
Note: Traditional assistive devices used alongside robotic training
“Further gait training was performed by having subjects utilize a lower limb orthosis and walking assistive devices (hip-knee-ankle-foot orthosis or ankle-foot orthosis with knee extension splint and wheeled triangular walker)”
Before and after every activity, routine general clinical evaluations performed including cardiovascular function assessment, intestinal and urinary emptying evaluation, skin inspection, and spasticity handling. Long-term osteoporosis treatment provided throughout protocol.
Note: Continuous monitoring for safety and health maintenance
“routine general clinical evaluations (i.e. cardiovascular function, intestinal and urinary emptying, skin inspection, spasticity handling), before and after every activity”
Repeat comprehensive clinical evaluations performed at 4-month timepoint using same assessment battery as baseline (Day 0).
Note: Same assessment tools as baseline
“were repeated after 4, 7, 10, and 12 months”
Repeat comprehensive clinical evaluations performed at 7-month timepoint using same assessment battery as baseline (Day 0).
Note: Same assessment tools as baseline
“were repeated after 4, 7, 10, and 12 months”
Repeat comprehensive clinical evaluations performed at 10-month timepoint using same assessment battery as baseline (Day 0).
Note: Same assessment tools as baseline
“were repeated after 4, 7, 10, and 12 months”
Final comprehensive clinical evaluations performed at 12-month timepoint using same assessment battery as baseline (Day 0).
Note: Same assessment tools as baseline; end of 12-month protocol
“were repeated after 4, 7, 10, and 12 months”
Throughout training, longitudinal EEG recordings performed to evaluate functional cortical plasticity. Patients instructed to imagine leg movements while EEG signals recorded from 11 scalp electrodes positioned over leg primary somatosensory and motor cortical areas.
Note: Assesses changes in brain representation of leg movements over time
“patients were instructed to imagine movements of their own legs while EEG signals from 11 scalp electrodes were recorded over the leg primary somatosensory and motor cortical areas”
Independent Component Analysis (ICA) employed to determine potential cortical sources represented by individual independent components (ICs) of novel leg representations in primary motor and somatosensory cortices. Detects functional changes of these representations over time.
Note: Statistical method for identifying brain sources of activity
“Independent Component Analysis (ICA) was employed to determine potential cortical sources, represented by individual independent components (ICs), of novel leg representations in the primary motor and somatosensory cortices”
For each independent component, Event Related Spectral Perturbations (ERSPs) calculated with respect to baseline of 1 second prior to event. Data normalized by average power across trials at each frequency. Performed before and after many months of training.
Note: Measures changes in brain oscillatory activity related to leg movement imagination
“we calculated for each IC the Event Related Spectral Perturbations (ERSPs) with respect to a baseline of 1 second prior to the event and normalized by the average power across trials at each frequency”
Event Related Potentials sampled from two EEG electrodes located over leg representation area. Data averaged over all patients before and after training. Used for statistical comparison of changes in brain responses.
Note: Measures evoked brain responses to leg movement imagination
“Event Related Potentials (ERPs), sampled from two EEG electrodes located over the leg representation area, averaged over all patients, before and after training, were also calculated and used for statistical comparison”
This section explains what the experiment is doing, which readouts matter, what the data artifacts usually look like, and how the analysis should flow from raw capture to reported result.
Comprehensive clinical neurological assessment of paraplegic patients with chronic spinal cord injury undergoing brain-machine interface neurorehabilitation training to evaluate changes in neurological status, physical function, and psychological well-being over 12 months
Objective
Comprehensive clinical neurological assessment of paraplegic patients with chronic spinal cord injury undergoing brain-machine interface neurorehabilitation training to evaluate changes in neurological status, physical function, and psychological well-being over 12 months
Subjects
From paperhuman • N/A • unknown • Not specified • 50-80 kg (exoskeleton accommodation range)
Sample count
From paper8
Cohort notes
From paperParaplegic patients with chronic spinal cord injury (>1 year duration); seven complete and one incomplete SCI
Patient enrollment and informed consent (Not specified)
Baseline clinical evaluation (Day 0) (Not specified)
Component 1: Immersive virtual reality BMI training (seated) (Not specified)
Component 2: Immersive virtual reality BMI training (upright) (Not specified)
ASIA Impairment Scale (neurological classification of spinal cord injury)
From paperIndependent Component Analysis (ICA) employed to determine cortical sources of leg representations.
Artifact type
Longitudinal gait metrics and per-animal performance tables
Comparison focus
Compare recovery trajectory across post-injury timepoints and treatment conditions
Semmes-Weinstein Monofilament Test (sensory function)
From paperIndependent Component Analysis (ICA) employed to determine cortical sources of leg representations.
Artifact type
Longitudinal gait metrics and per-animal performance tables
Comparison focus
Compare recovery trajectory across post-injury timepoints and treatment conditions
Temperature sensitivity
From paperIndependent Component Analysis (ICA) employed to determine cortical sources of leg representations.
Artifact type
Longitudinal gait metrics and per-animal performance tables
Comparison focus
Compare recovery trajectory across post-injury timepoints and treatment conditions
Vibration sensitivity
From paperIndependent Component Analysis (ICA) employed to determine cortical sources of leg representations.
Artifact type
Longitudinal gait metrics and per-animal performance tables
Comparison focus
Compare recovery trajectory across post-injury timepoints and treatment conditions
ASIA Impairment Scale (neurological classification of spinal cord injury)
From paperRaw artifact
Per-run gait capture with paw placement, timing, and stride features for each animal
Processed artifact
Cleaned gait metrics table and recovery trend summary across timepoints
Final reported form
Group comparisons of gait indices, stride metrics, or recovery curves
Semmes-Weinstein Monofilament Test (sensory function)
From paperRaw artifact
Per-run gait capture with paw placement, timing, and stride features for each animal
Processed artifact
Cleaned gait metrics table and recovery trend summary across timepoints
Final reported form
Group comparisons of gait indices, stride metrics, or recovery curves
Temperature sensitivity
From paperRaw artifact
Per-run gait capture with paw placement, timing, and stride features for each animal
Processed artifact
Cleaned gait metrics table and recovery trend summary across timepoints
Final reported form
Group comparisons of gait indices, stride metrics, or recovery curves
Vibration sensitivity
From paperRaw artifact
Per-run gait capture with paw placement, timing, and stride features for each animal
Processed artifact
Cleaned gait metrics table and recovery trend summary across timepoints
Final reported form
Group comparisons of gait indices, stride metrics, or recovery curves
Acquisition
Capture run-level gait data for each animal and preserve the timepoint or treatment labeling.
Preprocessing / cleaning
Independent Component Analysis (ICA) employed to determine cortical sources of leg representations.
Scoring or quantification
Quantify the primary readouts for this experiment: ASIA Impairment Scale (neurological classification of spinal cord injury); Semmes-Weinstein Monofilament Test (sensory function); Temperature sensitivity; Vibration sensitivity.
Statistical comparison
Statistical method not yet structured for this page.
Reporting output
Report representative outputs alongside summary comparisons for ASIA Impairment Scale (neurological classification of spinal cord injury), Semmes-Weinstein Monofilament Test (sensory function), Temperature sensitivity, Vibration sensitivity.
Source links and direct wording from the methods section for validation and deeper review.
Citation
Ana R. C. Donati et al. (2016). Long-Term Training with a Brain-Machine Interface-Based Gait Protocol Induces Partial Neurological Recovery in Paraplegic Patients. Scientific Reports
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Direct vendor pages are linked from the protocol above. This section stays focused on the full comparison view and the prep checklist.
Gather these items before starting the experiment. Check off items as you prepare.
Hocoma AG • Lokomat • Not specified • N/A
Aretech LLC. • ZeroG • Not specified • N/A
Custom built (research team) • Not specified • Not specified • N/A
Not specified • Not specified • Not specified • N/A
Oculus VR • Oculus Rift • Not specified • N/A
Hocoma AG • Lokomat • Not specified • N/A
Not specified • Not specified • Not specified • N/A
Not specified • Not specified • Not specified • N/A
Not specified • Hip-knee-ankle-foot orthosis or ankle-foot orthosis with knee extension splint • Not specified • N/A
Not specified • Not specified • Not specified • N/A
Autodesk • N/A
Not specified (standard statistical method) • N/A
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