The investigators aim to test whether intensive training of finger individuation during the sensitive window of the subacute phases can lead to a clinically-meaningful recovery of dexterous movement in stroke patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).
Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)
Loewenstein Rehabilitation Center
Raanana, Israel
RECRUITINGChange in Fugl-Meyer Assessment Score for Upper Extremity at the immediate post-intervention time
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in Fugl-Meyer Assessment Score for Upper Extermity at 1-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 1 month post-intervention
Change in Fugl-Meyer Assessment Score for Upper Extermity at 3-month post-intervention
A Likert-scale that quantifies movement quality, sensation, range of motion and pain in the upper limb following stroke. Range: 0 - 66. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 3 month post-intervention
Change in Individuation Index at the immediate post-intervention time
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in Individuation Index at 1-month post-intervention
The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time frame: Change from Baseline Score at 1-month post-intervention
Change in Individuation Index at 3-month post-intervention
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The relationship between forces (in Newton) in the active vs. passive fingers during a set of isolated finger movements. Higher numbers correlate with better finger-joint individuation, thus better dexterity.
Time frame: Change from Baseline Score at 3-month post-intervention
Arm Research Action Test (ARAT) Score at the immediate post-intervention time
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Tange: 0 - 57. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 1-3 days post-intervention
Arm Research Action Test (ARAT) Score at at 1-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 1-month post-intervention
Arm Research Action Test (ARAT) Score at at 3-month post-intervention
Time and quality of performance of 19 items mimicking activity of daily living, are measured. Range: 0 - 57. Higher values correlate with better motor control.
Time frame: Change from Baseline Score at 3-month post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at immediate post-intervention time
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in M1 MEP (motor evoked potentials) amplitude at 1-month post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time frame: Change from Baseline Score at 1-month post-intervention
Change in MEP (motor evoked potentials) amplitude at 3-months post-intervention
Stimulation of the ipsilesional M1 will be done (using either figure-of-eight, H- or dual-H rotational field coil) connected to TMS to elicit motor-evoked potential (MEP) of the first dorsal interosseous (FDI) muscle of the right hand, recorded with an EMG electrode. The peak-to-peak time will be computed off-line using MATLAB software. Higher MEP amplitudes correlate with higher cortico-spinal integrity.
Time frame: Change from Baseline Score at 3-months post-intervention
Change in extent of SICI (short-interval cortical inhibition) at the immediate post-intervention time
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time frame: Change from Baseline Score at 1-3 days post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 1-month post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time frame: Change from Baseline Score at 1-month post-intervention
Change in extent of SICI (short-interval cortical inhibition) at 3-months post-intervention
Single test pulses, conditioning pulses (five of each) and paired pulses (five pairs) at an inter-stimuli-interval (ISI) of 2 ms will be delivered to the motor cortex of both hemispheres. The intensity of the conditioning stimulus will be set at 80% of the subject's resting motor threshold (MT). The intensity of the test pulse will be 110% of the resting MT. The SICI will be measured as the reduction in conditioned MEPs relative to baseline MEPs. Higher SICI correlates with increased inhibitory activity of the motor cortex.
Time frame: Change from Baseline Score at 3-months post-intervention