Trial Outcomes & Findings for Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke (NCT NCT01948739)
NCT ID: NCT01948739
Last Updated: 2021-06-29
Results Overview
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
COMPLETED
NA
18 participants
Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment
2021-06-29
Participant Flow
18 were enrolled and allocated to the intervention, but only 10 received the intervention.
Participant milestones
| Measure |
BMI Control of MAHI Exo-II
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Overall Study
STARTED
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18
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Overall Study
Received Intervention
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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8
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke
Baseline characteristics by cohort
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Age, Continuous
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54.9 years
STANDARD_DEVIATION 9.2 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Hispanic
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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4 Participants
n=5 Participants
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Region of Enrollment
United States
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10 Participants
n=5 Participants
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Stroke Type
Hemorrhagic stroke
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5 Participants
n=5 Participants
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Stroke Type
Ischemic stroke
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5 Participants
n=5 Participants
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Stroke Location
Cortical lesion
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4 Participants
n=5 Participants
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Stroke Location
Subcortical lesion
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4 Participants
n=5 Participants
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Stroke Location
Cortical and subcortical lesion
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2 Participants
n=5 Participants
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Months Since Stroke
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37.4 months
STANDARD_DEVIATION 34.0 • n=5 Participants
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Paretic Arm
Right
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5 Participants
n=5 Participants
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Paretic Arm
Left
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5 Participants
n=5 Participants
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Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
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37.8 score on a scale
STANDARD_DEVIATION 11.7 • n=5 Participants
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Action Research Arm Test (ARAT)
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25.3 score on a scale
STANDARD_DEVIATION 16.8 • n=5 Participants
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Jebsen-Taylor Hand Function Test (JTHFT)
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1.046 items completed per second
STANDARD_DEVIATION 0.930 • n=5 Participants
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NIH Stroke Scale (NIHSS)
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3.4 score on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants
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Grip Strength
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11.13 kilograms of force
STANDARD_DEVIATION 8.7 • n=5 Participants
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Pinch Strength
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4.48 kilograms of force
STANDARD_DEVIATION 2.3 • n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatmentPopulation: 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant.
FMA is a stroke-specific, performance based impairment index. It quantitatively measures impairment based on Twitchell and Brunnstrom's concept of sequential stages of motor return in hemiplegic stroke patients. It uses an ordinal scale for scoring of 33 items for the upper limb component of the F-M scale (0:can not perform; 1:can perform partially; 2:can perform fully). Total range is 0-66, 0 being poor and 66 normal.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Baseline
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37.8 score on a scale
Standard Deviation 11.7
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Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Immediately after end of treatment (within a week)
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41.3 score on a scale
Standard Deviation 11.9
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Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
2 weeks after end of treatment
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47 score on a scale
Standard Deviation 10.5
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Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
12 weeks after end of treatment
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41.3 score on a scale
Standard Deviation 12.9
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. Increased MRCP amplitude indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
Baseline
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-1.49 microvolts
Standard Deviation 1.61
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Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
Immediately after end of treatment (within a week)
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-1.66 microvolts
Standard Deviation 1.53
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)EEG activity in the low-frequency delta band will be assessed. Scalp EEG electrodes will be located over the motor cortex, specifically, central (Cz, C1- C4), fronto- central (FCz, FC1 - FC4) and centro-parietal electrodes (CPz, CP1 - CP4). Further, to account for left hand vs. right hand impairment, the electrode locations will be flipped for individuals with right hand impairment. MRCP latency is the duration of MRCP prior to movement onset, and is defined as time difference starting from 50% of peak amplitude until the time of movement onset. Increased MRCP latency indicates increased activation of the ipsi-lesional hemisphere or inhibition of competing contra-lesional hemisphere, following motor relearning.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Baseline
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486.10 milliseconds
Standard Deviation 92.56
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Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Immediately after end of treatment (within a week)
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459.90 milliseconds
Standard Deviation 109.60
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)A higher value indicates better movement quality.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
Baseline
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15.80 degrees per second
Standard Deviation 8.28
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Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
Immediately after end of treatment (within a week)
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20.08 degrees per second
Standard Deviation 7.29
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)Spectral Arc Length is a frequency-domain measure that increases in value as movements become less jerky. A higher value indicates better movement quality (that is, movements are less jerky).
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Baseline
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-2.64 unitless
Standard Deviation 0.95
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Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Immediately after end of treatment (within a week)
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-2.29 unitless
Standard Deviation 0.47
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)Number of peaks is a metric related to the shape of the velocity profile. A higher number of peaks implies jerkier movement. A lower number of peaks indicates better movement quality (that is, movements are less jerky).
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Baseline
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2.13 number of peaks
Standard Deviation 0.76
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Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Immediately after end of treatment (within a week)
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1.78 number of peaks
Standard Deviation 0.81
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PRIMARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week)Time to 1st Peak is a metric related to the shape of the velocity profile, and is reported as \[(time to first peak) divided by (total movement duration)\]. This value is usually less than the ideal value of 0.5, or 50%, of the total movement duration when a movement has more than one peak. The closer the value is to the ideal value of 0.5, the more well-balanced are the movements.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Baseline
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0.35 seconds
Standard Deviation 0.14
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Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Immediately after end of treatment (within a week)
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0.43 seconds
Standard Deviation 0.16
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SECONDARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatmentPopulation: 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant.
The ARAT is used to assess subject's ability to manipulate-lift-release objects horizontally and vertically, which differs in size, weight and shape. The test consists of 19 items divided into 4 sub-tests (grasp, grip, pinch, gross arm movement) and each item is rated on a 4-point scale. The possible total score ranges between 0-57. Higher scores indicate better performance.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Score on Action Research Arm Test (ARAT)
Baseline
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25.30 score on a scale
Standard Deviation 16.80
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Score on Action Research Arm Test (ARAT)
Immediately after end of treatment (within a week)
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30.50 score on a scale
Standard Deviation 20.89
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Score on Action Research Arm Test (ARAT)
2 weeks after end of treatmen
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34.71 score on a scale
Standard Deviation 17.16
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Score on Action Research Arm Test (ARAT)
12 weeks after end of treatment
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30.33 score on a scale
Standard Deviation 21.49
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SECONDARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatmentPopulation: 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant.
The JTHFT is a motor performance test and assesses the time needed to perform 7 everyday activities (for example, flipping cards and feeding). Score is reported as items completed per second.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Score on Jebsen-Taylor Hand Function Test (JTHFT)
Baseline
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1.05 activities completed per second
Standard Deviation 0.93
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Score on Jebsen-Taylor Hand Function Test (JTHFT)
Immediately after end of treatment (within a week)
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1.00 activities completed per second
Standard Deviation 0.88
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Score on Jebsen-Taylor Hand Function Test (JTHFT)
2 weeks after end of treatment
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1.32 activities completed per second
Standard Deviation 0.86
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Score on Jebsen-Taylor Hand Function Test (JTHFT)
12 weeks after end of treatment
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1.11 activities completed per second
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatmentPopulation: 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant.
A grip dynamometer will be used to measure maximum gross grasp force.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Grip Strength
Baseline
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11.13 kg of force
Standard Deviation 8.70
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Grip Strength
Immediately after end of treatment (within a week)
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12.64 kg of force
Standard Deviation 9.91
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Grip Strength
2 weeks after end of treatment
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13.33 kg of force
Standard Deviation 9.19
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Grip Strength
12 weeks after end of treatment
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12.26 kg of force
Standard Deviation 9.42
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SECONDARY outcome
Timeframe: Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatmentPopulation: 2 weeks after end of treatment, data for this outcome measure were not collected for 3 participants. 12 weeks after end of treatment, data for this outcome measure was not collected for 1 participant.
A pinch gauge will be used to measure maximum pinch force.
Outcome measures
| Measure |
BMI Control of MAHI Exo-II
n=10 Participants
MAHI EXO-II exoskeleton augmented with BMI system will be used to actively include the patient in the control loop, thereby making the therapy 'active' and engaging patients with various impairment severity in rehabilitation tasks. Patients will receive longitudinal training with the BMI-robotic interface for 3-4 sessions per week, over a period of 3 months.
MAHI EXO-II exoskeleton augmented with BMI system: In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
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Pinch Strength
Baseline
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4.48 kg of force
Standard Deviation 2.29
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Pinch Strength
Immediately after end of treatment (within a week)
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5.01 kg of force
Standard Deviation 2.53
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Pinch Strength
2 weeks after end of treatment
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5.47 kg of force
Standard Deviation 1.30
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Pinch Strength
12 weeks after end of treatment
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4.55 kg of force
Standard Deviation 1.45
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Adverse Events
BMI Control of MAHI Exo-II
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place