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| ID | Type | Description | Link |
|---|---|---|---|
| R21NS118435 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This project will develop and test a new paradigm of motor imagery for facilitating neuromotor excitability and performance of distal muscles in the upper limb by adopting a robotic prosthesis and integrating proven procedures for neuromotor facilitation. The scientific purpose of the study is to understand the effect of controlling a detached robotic prosthesis with proximal muscle activation on brain excitability of the resting arm muscles as well as reaction time. The efficacy of this task will be understood by comparing with other task conditions (motor imagery only, 2D visual feedback on a monitor, etc.) that do not involve the robotic prosthesis. The test of the developed system will be performed in healthy able-bodied adults. The feasibility of the system will be examined in post-stroke adults.
This study consists of experiments on two non-consecutive days in the Human Neuromuscular Physiology Laboratory located in the Biological Sciences/Applied Physiology Building of Georgia Tech. If subjects qualify and agree to take part in this study, subjects will be asked to read and sign the consent form. The whole procedure will last about 3 hours per day, including preparation. Subjects will come to the lab on two separate days on the same tasks. The first day will serve as familiarization with the same tasks as the second day. Subjects will perform the following experiment. Individuals will sit upright and relax their hands and shoulders. The right hand and forearm will be rested on a plate hidden below a table. The robotic hand will be placed on the table as one would normally place own arm on the table. There will be no physical connection between the hand and the robotic hand. Subjects will activate the abdominal muscles for making a grasping movement of the robotic hand. For making a releasing movement of the robotic hand, subjects will activate the back muscles. Muscle activity will be recorded with two small sensors on each muscle. Subjects will practice activation of each muscle while watching the signal on a monitor. In each muscle, a clearer signal will be used for controlling the robotic digits. Healthy subjects only: Healthy subjects will perform the following tasks A-F. [A: Rest] Subjects will relax the muscles without physical or cognitive effort while gazing at the turned-off monitor. [B: Robotic action observation] Subjects will relax the muscles and focus on observing the computer-controlled grasp and release actions (2 s in each movement) of the robotic prosthesis. [C: Visual MI] Subjects will relax the muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will image the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. [D: Kinesthetic MI] The same MI procedure as Task C will be performed, except that the subjects will focus on the kinesthetic sensation that was felt with the imaged motions. [E: Robotic-Hand Interaction with MI] Subjects will perform robotically augmented mental practice (see below detailed description) for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also image the kinesthetic sensation that was felt with the corresponding motions with the right arm. [F: Virtual-Hand Interaction robot] Subjects will perform Task E with visual feedback of virtual robot actions in 2D on a monitor. [G: Robotic-Hand Interaction without MI] Subjects will perform Task E without MI. As a reaction task, subjects will flex the index finger as soon as they hear an auditory cue. Post-stroke subjects only: Tasks C [Visual MI], E [Robotic-Hand Interaction with MI], and A [Rest] above will be performed by post-stroke subjects with right-side hemiparesis who can volitionally activate fingers and proximal muscles. As a reaction task, subjects will flex the index finger as soon as an auditory cue is heard. TMS (both healthy and post-stroke subjects): During the above-mentioned tasks, brain stimulation (called TMS) will be applied over the motor cortex in the left hemisphere. The TMS procedure will follow the one used in the previous studies by the investigators. A TMS coil will be placed over a precise point on the scalp where the investigators will stimulate the brain to make the muscle move. The investigators will tell the subject when the stimulation portion of the procedure is about to begin. The first part of the procedure will be to find the area of the brain that controls muscles. These investigators will position the TMS coil on the head and will give the subject a series of stimulations (called magnetic pulses). Once the spot that controls the muscles is identified, the investigators will find the least amount of stimulation needed to activate the resting muscles. The second part of the procedure will be to evoke muscle contraction with TMS at rest and during the tasks described above. The investigators will apply TMS with 5-second intervals or more. Robotically augmented practice (Task E and F above): An individual will use proximal muscle contractions to flex and extend the robotic prosthesis digits for performing a grasp-release task. 1) Grasp. The individual will activate the proximal muscles as if for a retrieving motion (the back muscles) for 2 s. This muscle activation controls the robotic hand to flex the digits to grasp a cylinder-shaped object. 2) Release. The individual will relax the above-activated proximal muscles and activate the proximal muscles as if for a reaching motion (the abdominal muscles) for 2 s. This muscle activation controls the robotic hand to extend the digits to release the object. After releasing the object, the individual will relax the proximal muscles. The individual will repeat this sequence while observing and hearing the actions of the robotic hand.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy participants | Experimental | All participants will receive seven types of interventions in random order. The types of interventions are the same across subjects. |
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| Post-Stroke participants | Experimental | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Visual motor imagery (MI) | Behavioral | Subjects will relax their muscles and perform conventional visual motor imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. |
| Measure | Description | Time Frame |
|---|---|---|
| MEP Amplitude | Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle | 1 day |
| Reaction Time | Reaction time of the index finger in response to an auditory cue (reaction time test) | 1 day |
| Peak EMG | Peak EMG amplitude of the hand muscle during the reaction time test was determined in each intervention. After identifying the maximal peak EMG value among the interventions, peak EMG value in each task was normalized to that maximal peak EMG, expressed as the ratio. | 1 day |
| Maximal Rate of Force Development | Maximal rate of force development during a reaction time test | 1 day |
| Peak Force | Peak force of the index finger during a reaction time test | 1 day |
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Inclusion Criteria for Healthy able-bodied volunteers:
Inclusion Criteria for Right-handed Post-stroke adults:
Exclusion Criteria for both healthy and post-stroke individuals: To ensure the safety associated with TMS, the following adults will be excluded (*, not applicable to post-stroke subjects):
Additional Exclusion Criteria for post-stroke adults:
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| Name | Affiliation | Role |
|---|---|---|
| Minoru Shinohara, Ph.D. | Georgia Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Neuromuscular Physiology Lab | Atlanta | Georgia | 30332 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Participants | (Cross-over design but presented as a single group because of many sequences) All participants will receive seven types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery: Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Kinesthetic MI: The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Robotic-hand interaction without MI: Subjects will perform the robotically augmented practice without MI. Virtual-hand interaction: Subjects will perform the augmented practice with visual feedback of virtual robot actions on a monitor. Robotic action observation: Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand. Rest: Subjects will rest without a task. |
| FG001 | Post-Stroke Participants | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery: Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Rest: Subjects will rest without a task. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Motor Imagery |
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| Robotic-hand Interaction With MI |
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| Robotic-hand Interaction Without MI |
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| Virtual-hand Interaction |
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| Robotic Action Observation |
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| Rest |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Participants | All participants will receive various types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery (MI): Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Kinesthetic MI: The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Robotic-hand interaction without MI: Subjects will perform the robotically augmented practice without MI. Virtual-hand interaction: Subjects will perform the augmented practice with visual feedback of virtual robot actions on a monitor. Robotic action observation: Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand. Rest: Subjects will rest without a task. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MEP Amplitude | Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle | Post-stroke data were not included in the overall statistical tests because they have distinct neuromotor characteristics and cannot be mixed with healthy samples. Post-stroke data were not statistically tested independently either because the number of subjects is too small to achieve appropriate statistical power. This strategy was as originally planned. | Posted | Mean | Standard Deviation | mV | 1 day |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Participants | All participants will receive various types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery (MI): Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Kinesthetic MI: The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Robotic-hand interaction: Subjects will perform the robotically augmented practice without MI. Virtual-hand interaction: Subjects will perform the augmented practice with visual feedback of virtual robot actions on a monitor. Robotic action observation: Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand. Rest: Subjects will rest without a task. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Minoru Shinohara | Georgia Institute of Technology | 404-894-1030 | shinohara@gatech.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 25, 2023 | Aug 25, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 20, 2023 | Sep 27, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C092779 | RE1-silencing transcription factor |
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Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.
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| Kinesthetic MI | Behavioral | The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions. |
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| Robotic-Hand Interaction with MI | Behavioral | Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. |
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| Robotic-Hand Interaction without MI | Behavioral | Subjects will perform the Robot-Hand Interaction without MI. |
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| Virtual-Hand Interaction | Behavioral | Subjects will interact with visual feedback of virtual robot actions on a monitor. |
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| Robotic Action Observation | Behavioral | Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand. |
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| Rest | Behavioral | Subjects will rest without a task. |
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| BG001 | Post-Stroke Participants | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery: Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Rest: Subjects will rest without a task. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Post-Stroke Participants | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery (MI): Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Robotic-Hand Interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Rest: Subjects will rest without a task. |
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| Primary | Reaction Time | Reaction time of the index finger in response to an auditory cue (reaction time test) | Post-stroke data were not included in the overall statistical tests because they have distinct neuromotor characteristics and cannot be mixed with healthy samples. Post-stroke data were not statistically tested independently either because the number of subjects is too small to achieve appropriate statistical power. This strategy was as originally planned. | Posted | Mean | Standard Deviation | ms | 1 day |
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| Primary | Peak EMG | Peak EMG amplitude of the hand muscle during the reaction time test was determined in each intervention. After identifying the maximal peak EMG value among the interventions, peak EMG value in each task was normalized to that maximal peak EMG, expressed as the ratio. | Post-stroke data were not included in the overall statistical tests because they have distinct neuromotor characteristics and cannot be mixed with healthy samples. Post-stroke data were not statistically tested independently either because the number of subjects is too small to achieve appropriate statistical power. This strategy was as originally planned. | Posted | Mean | Standard Deviation | Ratio | 1 day |
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| Primary | Maximal Rate of Force Development | Maximal rate of force development during a reaction time test | Post-stroke data were not included in the overall statistical tests because they have distinct neuromotor characteristics and cannot be mixed with healthy samples. Post-stroke data were not statistically tested independently either because the number of subjects is too small to achieve appropriate statistical power. This strategy was as originally planned. | Posted | Mean | Standard Deviation | N/s | 1 day |
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| Primary | Peak Force | Peak force of the index finger during a reaction time test | Post-stroke data were not included in the overall statistical tests because they have distinct neuromotor characteristics and cannot be mixed with healthy samples. Post-stroke data were not statistically tested independently either because the number of subjects is too small to achieve appropriate statistical power. This strategy was as originally planned. | Posted | Mean | Standard Deviation | N | 1 day |
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| 0 |
| 19 |
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| 19 |
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| 19 |
| EG001 | Post-Stroke Participants | All participants will receive three types of interventions in random order. The types of interventions are the same across subjects. Visual motor imagery (MI): Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction. Robotic-hand interaction with MI: Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm. Rest: Subjects will rest without a task. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Kinesthetic Motor Imagery |
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| Robotic-Hand Interaction with MI |
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| Robotic-Hand Interaction without MI |
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| Virtual-Hand Interaction |
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| Robotic Action Observation |
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| Rest |
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| Kinesthetic Motor Imagery |
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| Robotic-Hand Interaction with MI |
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| Robotic-Hand Interaction without MI |
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| Virtual-Hand Interaction |
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| Robotic Action Observation |
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| Rest |
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| Kinesthetic Motor Imagery |
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| Robotic-Hand Interaction with MI |
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| Robotic-Hand Interaction without MI |
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| Virtual-Hand Interaction |
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| Robotic Action Observation |
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| Rest |
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| Kinesthetic Motor Imagery |
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| Robotic-Hand Interaction with MI |
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| Robotic-Hand Interaction without MI |
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| Virtual-Hand Interaction |
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| Robotic Action Observation |
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| Rest |
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