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Robotically Augmented Mental Practice

Robotically Augmented Mental Practice for Neuromotor Facilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04962698
Enrollment
25
Registered
2021-07-15
Start date
2022-05-11
Completion date
2023-05-16
Last updated
2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Hand, Imagery, Robot

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVisual motor imagery (MI)

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.

BEHAVIORALKinesthetic 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.

BEHAVIORALRobotic-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.

BEHAVIORALRobotic-Hand Interaction without MI

Subjects will perform the Robot-Hand Interaction without MI.

BEHAVIORALVirtual-Hand Interaction

Subjects will interact with visual feedback of virtual robot actions on a monitor.

BEHAVIORALRobotic Action Observation

Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic hand.

BEHAVIORALRest

Subjects will rest without a task.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Georgia Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Participants in a single group will receive various types of interventions in random order. The types of interventions are the same across subjects.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

for Healthy able-bodied volunteers: * 18-39 years old, men and women Inclusion Criteria for Right-handed Post-stroke adults: * 21-75 years old * Right-handed * Longer than 6 months post-stroke * Persistent hemiparesis on the right upper extremity (UE) * Residual UE voluntary movement as indicated by a score of 1-3 on the motor arm item of the NIH Stroke Scale (NIHSS) and a score of 19-55 on the UE portions of the Fugl Meyer Assessment (UE-FMA) * Preserved cognitive function * Ability to follow and read simple instructions as indicated by a score of 1 or above on item #9 on the best language items of the NIHSS

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): * Had an adverse reaction to TMS. Had epilepsy or seizure. * Have any implanted devices such as a neurostimulator or cochlear implant. * Had a stroke or lesion (including tumor) in your brain\*. Had a head injury or brain surgery\*. * Suffer from frequent or severe headaches. * Had a fainting spell or syncope. * Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metalwork. * Have any implanted device such as cardiac pacemakers, medical pumps, or intra-cardiac lines. * Had any brain-related conditions\*. * Had any illness that caused brain injury\* (i.e. meningitis, aneurysm, brain tumor). * Had any head trauma that was associated with a loss of consciousness or diagnosed as a concussion. * Being treated for any psychiatric condition (i.e. depression, anxiety, PTSD, schizophrenia). * Had more than 2 cups of coffee/caffeinated beverages in the last 12 hours. * Had more than 2 alcoholic beverages in the last 12 hours. * Had less than 6 hours of sleep in the last 24 hours. * Suspected of pregnancy. Additional

Design outcomes

Primary

MeasureTime frameDescription
MEP Amplitude1 dayPeak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle
Reaction Time1 dayReaction time of the index finger in response to an auditory cue (reaction time test)
Peak EMG1 dayPeak 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.
Maximal Rate of Force Development1 dayMaximal rate of force development during a reaction time test
Peak Force1 dayPeak force of the index finger during a reaction time test

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
19
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.
6
Total25

Withdrawals & dropouts

PeriodReasonFG000FG001
Kinesthetic MITechnical difficulty10
Motor ImageryExclusion criteria met after enrollment02
Motor ImageryTechnical difficulty10
RestExclusion criteria met after enrollment02
RestTechnical difficulty10
Robotic Action ObservationTechnical difficulty10
Robotic-hand Interaction With MIExclusion criteria met after enrollment02
Robotic-hand Interaction With MITechnical difficulty10
Robotic-hand Interaction Without MITechnical difficulty10
Virtual-hand InteractionTechnical difficulty10

Baseline characteristics

CharacteristicHealthy ParticipantsPost-Stroke ParticipantsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
19 Participants6 Participants25 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants6 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants0 Participants7 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
3 Participants0 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
7 Participants5 Participants12 Participants
Region of Enrollment
United States
19 participants6 participants25 participants
Sex: Female, Male
Female
11 Participants2 Participants13 Participants
Sex: Female, Male
Male
8 Participants4 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 190 / 6
other
Total, other adverse events
0 / 190 / 6
serious
Total, serious adverse events
0 / 190 / 6

Outcome results

Primary

Maximal Rate of Force Development

Maximal rate of force development during a reaction time test

Time frame: 1 day

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsMaximal Rate of Force DevelopmentVirtual-Hand Interaction57.0 N/sStandard Deviation 57.3
Healthy ParticipantsMaximal Rate of Force DevelopmentRobotic Action Observation39.1 N/sStandard Deviation 33.2
Healthy ParticipantsMaximal Rate of Force DevelopmentRest40.8 N/sStandard Deviation 48.1
Healthy ParticipantsMaximal Rate of Force DevelopmentKinesthetic Motor Imagery42.9 N/sStandard Deviation 33
Healthy ParticipantsMaximal Rate of Force DevelopmentRobotic-Hand Interaction with MI56.7 N/sStandard Deviation 53.9
Healthy ParticipantsMaximal Rate of Force DevelopmentMotor Imagery44.0 N/sStandard Deviation 39.8
Healthy ParticipantsMaximal Rate of Force DevelopmentRobotic-Hand Interaction without MI61.6 N/sStandard Deviation 61.5
Post-Stroke ParticipantsMaximal Rate of Force DevelopmentRest20.0 N/sStandard Deviation 15.4
Post-Stroke ParticipantsMaximal Rate of Force DevelopmentMotor Imagery12.6 N/sStandard Deviation 6.7
Post-Stroke ParticipantsMaximal Rate of Force DevelopmentRobotic-Hand Interaction with MI23.0 N/sStandard Deviation 15.9
p-value: <0.00231Wilcoxon (Mann-Whitney)
Primary

MEP Amplitude

Peak-to-peak amplitude of motor evoked potential (MEP) of the hand muscle

Time frame: 1 day

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsMEP AmplitudeMotor Imagery0.813 mVStandard Deviation 0.8
Healthy ParticipantsMEP AmplitudeVirtual-Hand Interaction1.197 mVStandard Deviation 1.01
Healthy ParticipantsMEP AmplitudeRobotic Action Observation0.899 mVStandard Deviation 0.652
Healthy ParticipantsMEP AmplitudeRest1.106 mVStandard Deviation 0.715
Healthy ParticipantsMEP AmplitudeKinesthetic Motor Imagery0.916 mVStandard Deviation 0.695
Healthy ParticipantsMEP AmplitudeRobotic-Hand Interaction with MI1.237 mVStandard Deviation 1.01
Healthy ParticipantsMEP AmplitudeRobotic-Hand Interaction without MI1.019 mVStandard Deviation 0.823
Post-Stroke ParticipantsMEP AmplitudeMotor Imagery0.475 mVStandard Deviation 0.3
Post-Stroke ParticipantsMEP AmplitudeRobotic-Hand Interaction with MI0.451 mVStandard Deviation 0.307
Post-Stroke ParticipantsMEP AmplitudeRest0.810 mVStandard Deviation 0.567
p-value: >0.00238Wilcoxon (Mann-Whitney)
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.

Time frame: 1 day

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsPeak EMGMotor Imagery0.602 RatioStandard Deviation 0.292
Healthy ParticipantsPeak EMGVirtual-Hand Interaction0.683 RatioStandard Deviation 0.302
Healthy ParticipantsPeak EMGRobotic Action Observation0.488 RatioStandard Deviation 0.288
Healthy ParticipantsPeak EMGRest0.530 RatioStandard Deviation 0.256
Healthy ParticipantsPeak EMGKinesthetic Motor Imagery0.602 RatioStandard Deviation 0.277
Healthy ParticipantsPeak EMGRobotic-Hand Interaction with MI0.721 RatioStandard Deviation 0.29
Healthy ParticipantsPeak EMGRobotic-Hand Interaction without MI0.699 RatioStandard Deviation 0.311
Post-Stroke ParticipantsPeak EMGMotor Imagery0.517 RatioStandard Deviation 0.32
Post-Stroke ParticipantsPeak EMGRobotic-Hand Interaction with MI0.954 RatioStandard Deviation 0.093
Post-Stroke ParticipantsPeak EMGRest0.599 RatioStandard Deviation 0.313
p-value: 0.028ANOVA
Primary

Peak Force

Peak force of the index finger during a reaction time test

Time frame: 1 day

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsPeak ForceMotor Imagery4.369 NStandard Deviation 4.018
Healthy ParticipantsPeak ForceVirtual-Hand Interaction5.105 NStandard Deviation 5.464
Healthy ParticipantsPeak ForceRobotic Action Observation3.741 NStandard Deviation 3.385
Healthy ParticipantsPeak ForceRest3.537 NStandard Deviation 3.878
Healthy ParticipantsPeak ForceKinesthetic Motor Imagery4.370 NStandard Deviation 4.01
Healthy ParticipantsPeak ForceRobotic-Hand Interaction with MI5.342 NStandard Deviation 5.557
Healthy ParticipantsPeak ForceRobotic-Hand Interaction without MI5.666 NStandard Deviation 5.553
Post-Stroke ParticipantsPeak ForceMotor Imagery1.968 NStandard Deviation 1.869
Post-Stroke ParticipantsPeak ForceRobotic-Hand Interaction with MI3.708 NStandard Deviation 3.378
Post-Stroke ParticipantsPeak ForceRest3.312 NStandard Deviation 4.107
p-value: <0.002Wilcoxon (Mann-Whitney)
Primary

Reaction Time

Reaction time of the index finger in response to an auditory cue (reaction time test)

Time frame: 1 day

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsReaction TimeVirtual-Hand Interaction273.4 msStandard Deviation 44.2
Healthy ParticipantsReaction TimeRest234.2 msStandard Deviation 38.7
Healthy ParticipantsReaction TimeRobotic-Hand Interaction with MI275.7 msStandard Deviation 51.5
Healthy ParticipantsReaction TimeRobotic-Hand Interaction without MI271.7 msStandard Deviation 38.3
Healthy ParticipantsReaction TimeRobotic Action Observation259.9 msStandard Deviation 38.2
Healthy ParticipantsReaction TimeMotor Imagery293.6 msStandard Deviation 43
Healthy ParticipantsReaction TimeKinesthetic Motor Imagery286.4 msStandard Deviation 57.5
Post-Stroke ParticipantsReaction TimeRest362.8 msStandard Deviation 94.4
Post-Stroke ParticipantsReaction TimeRobotic-Hand Interaction with MI378.6 msStandard Deviation 107
Post-Stroke ParticipantsReaction TimeMotor Imagery522.0 msStandard Deviation 205.4
p-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026