The study's main goal is to determine if clinical and physiological effects of a brain-computer interface intervention for the neurorehabilitation of stroke patients' upper limb are greater than the effects of a sham robotic feedback. For this purpose a randomized controlled trial will be performed to compare somatosensory sham robotic feedback with the same somatosensory feedback controlled with the brain-computer interface output.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.
Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra Ibarra (National Institute of Rehabilitation)
Tlalpan, Mexico City, Mexico
Mean change from baseline in upper limb motor function on the Fugl-Meyer Assessment for the Upper Extremity
Analysis of changes on the Fugl-Meyer Assessment for the Upper Extremity will reveal if there is a clinical significant sensorimotor function compared to baseline
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in upper limb motor function on the Action Research Arm Test
Analysis of changes on the Action Research Arm Test will reveal if there is a clinical significant motor function compared to baseline
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in cortical activity measured with Functional Magnetic Resonance Imaging
Blood-oxygen-level-dependent imaging will be analyzed to assess if there are changes in cortical activity compared to baseline.
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in corticospinal excitability measured with Transcranial Magnetic Stimulation
Motor Evoked Potentials parameters will reveal if there are changes of corticospinal excitability in both hemibodies compared to baseline
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
Mean change from baseline in grip strength measured with a dynamometer
Analysis of hand strength measurements will reveal if there were changes compared to baseline
Time frame: At enrollment, 3 weeks after the intervention onset, 6 weeks after the intervention onset, and 24 weeks after the intervention onset
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.