Brain Machine Interface Control of an Robotic Exoskeleton in Training Upper Extremity Functions in Stroke

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT01948739
• Collaborator: University of Houston (Other), The Methodist Hospital Research Institute (Other), National Institute of Neurological Disorders and Stroke (NINDS) (NIH), TIRR Memorial Hermann (Other)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 55.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is:

1. To augment the MAHI Exo-II, a physical human exoskeleton, with a non-invasive brain machine interface (BMI) to actively include patient in the control loop and thereby making the therapy 'active'.

2. To determine appropriate robotic (kinematic data acquired through sensors on robotic device ) and electrophysiological ( electroencephalography- EEG based) measures of arm motor impairment and recovery after stroke.

3. To demonstrate that the BMI controlled MAHI Exo-II robotic arm training is feasible and effective in improving arm motor functions in sub-acute and chronic stroke population.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Hemiparesis	Device: MAHI EXO-II exoskeleton augmented with BMI system	N/A

Detailed Description

This study aims to provide an adjunct to accelerate neurorehabilitation for stroke patients. The MAHI EXO-II, a physical human-robot interface, will be combined with a non-invasive brain-machine interface (BMI) to actively include the patient in the training of upper extremity motor functions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: NRI:BMI Control of a Therapeutic Exoskeleton
• Actual Study Start Date: Sep 24, 2013
• Actual Primary Completion Date: Apr 28, 2018
• Actual Study Completion Date: Apr 28, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Device: 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.; Other Names: Brain Machine Interface System Rehabilitation robotics

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score [Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment]

   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.

2. Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude [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.

3. Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency [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.

4. Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed [Baseline, immediately after end of treatment (within a week)]

   A higher value indicates better movement quality.

5. Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length [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).

6. Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks [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).

7. Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak [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.

Secondary Outcome Measures

1. Score on Action Research Arm Test (ARAT) [Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment]

   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.

2. Score on Jebsen-Taylor Hand Function Test (JTHFT) [Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment]

   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.

3. Grip Strength [Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment]

   A grip dynamometer will be used to measure maximum gross grasp force.

4. Pinch Strength [Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment]

   A pinch gauge will be used to measure maximum pinch force.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Diagnosis of unilateral cortical and subcortical stroke confirmed by brain CT or MRI scan;

2. Subacute or chronic stroke; interval of at least 3month and interval of at least 6 months from stroke to time of enrollment, respectively;

3. No previous clinically defined stroke;

4. Age between 18-75 years;

5. Upper-extremity hemiparesis associated with stroke (manual muscle testing score of at least 2, but no more than 4/5 in the elbow and wrist flexors);

6. No joint contracture or severe spasticity in the affected upper extremity: i.e., significant increase in muscle tone against passive ROM is no more than ½ of full range for given joint e.g., elbow, wrist and forearm movements.

7. Sitting balance sufficient to participate with robotic activities;

8. No neglect that would preclude participation in the therapy protocol;

9. Upper limb proprioception present ( as tested by joint position sense of wrist);

10. No history of neurolytic procedure to the affected limb in the past four months and no planned alteration in upper-extremity therapy or medication for muscle tone during the course of the study;

11. No medical or surgical condition that will preclude participation in an occupational therapy program, that includes among others, strengthening, motor control and functional re-training of the upper limbs;

12. No contraindication to MRI;

13. No condition (e.g., severe arthritis, central pain) that would interfere with valid administration of the motor function tests;

14. English-language comprehension and cognitive ability sufficient to give informed consent and to cooperate with the intervention.-

Exclusion Criteria:

1. Orthopedic limitations of either upper extremity that would affect performance on the study;

2. Untreated depression that may affect motivation to participate in the study;

3. Subjects who cannot provide self-transportation to the study location.

Inclusion and Exclusion Criteria for Health Subjects:

Inclusion criteria:

• able to understand and sign the consent form

• age 18-65

Exclusion criteria: - Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations - Contraindication to MRI - Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann	Houston	Texas	United States	77030

Sponsors and Collaborators

• The University of Texas Health Science Center, Houston
• University of Houston
• The Methodist Hospital Research Institute
• National Institute of Neurological Disorders and Stroke (NINDS)
• TIRR Memorial Hermann

Investigators

• Principal Investigator: Marcia K. O'Malley, PhD, William Marsh Rice University
• Principal Investigator: Jose L. Contreras-Vidal, PhD, University of Houston
• Principal Investigator: Gerard Francisco, MD, The University of Texas Health Science Center, Houston
• Principal Investigator: Robert G. Grossman, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 11, 2016

More Information

Additional Information:

• Mechatronics and Haptic Interfaces (MAHI) Lab (Dr.O'Malley, Rice Uni)
• University of Houston Brain-Machine Interface System Team (Dr.Contreras-Vidal, UH)
• The UTHealth Motor Recovery Lab at TIRR Memorial Hermann Hospital (Dr.Francisco, UTHealth)

Publications

• A. Gupta, V. Patolgu, M.K. O'Malley, and C.M. Burgar (2008). Design, Control and Performance of RiceWrist: A Force Feedback Wrist Exoskeleton for Rehabilitation and Training, International Journal of Robotics Research (IJRR) 27(2): 233-51.
• Bhagat NA, French J, Venkatakrishnan A, Yozbatiran N, Francisco GE, O'Malley MK, Contreras-Vidal JL. Detecting movement intent from scalp EEG in a novel upper limb robotic rehabilitation system for stroke. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:4127-4130. doi: 10.1109/EMBC.2014.6944532.
• Bhagat NA, Venkatakrishnan A, Abibullaev B, Artz EJ, Yozbatiran N, Blank AA, French J, Karmonik C, Grossman RG, O'Malley MK, Francisco GE, Contreras-Vidal JL. Design and Optimization of an EEG-Based Brain Machine Interface (BMI) to an Upper-Limb Exoskeleton for Stroke Survivors. Front Neurosci. 2016 Mar 31;10:122. doi: 10.3389/fnins.2016.00122. eCollection 2016.
• Bradberry TJ, Gentili RJ, Contreras-Vidal JL. Fast attainment of computer cursor control with noninvasively acquired brain signals. J Neural Eng. 2011 Jun;8(3):036010. doi: 10.1088/1741-2560/8/3/036010. Epub 2011 Apr 15.
• Yozbatiran N, Berliner J, O'Malley MK, Pehlivan AU, Kadivar Z, Boake C, Francisco GE. Robotic training and clinical assessment of upper extremity movements after spinal cord injury: a single case report. J Rehabil Med. 2012 Feb;44(2):186-8. doi: 10.2340/16501977-0924.

• Responsible Party: Marcia k. O'Malley, Associate Professor of Mechanical Engineering, William Marsh Rice University
• ClinicalTrials.gov Identifier: NCT01948739
• Other Study ID Numbers: HSC-MS-13-0054; 1R01NS081854
• First Posted: Sep 24, 2013
• Last Update Posted: Jun 29, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Marcia k. O'Malley, Associate Professor of Mechanical Engineering, William Marsh Rice University: Brain machine interface; Rehabilitation robotics; Stroke; Hemiparesis
• Additional relevant MeSH terms: Stroke; Paresis

Study Results

Participant Flow

Pre-assignment Detail	18 were enrolled and allocated to the intervention, but only 10 received the intervention.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Period Title: Overall Study
STARTED	18
Received Intervention	10
COMPLETED	10
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.9 (9.2)
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%
Race/Ethnicity, Customized (Count of Participants)
Asian	2 20%
Black or African American	2 20%
Hispanic	2 20%
White	4 40%
Region of Enrollment (Count of Participants)
United States	10 100%
Stroke Type (Count of Participants)
Hemorrhagic stroke	5 50%
Ischemic stroke	5 50%
Stroke Location (Count of Participants)
Cortical lesion	4 40%
Subcortical lesion	4 40%
Cortical and subcortical lesion	2 20%
Months Since Stroke (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	37.4 (34.0)
Paretic Arm (Count of Participants)
Right	5 50%
Left	5 50%
Fugl-Meyer Assessment-Upper Extremity (FMA-UE) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	37.8 (11.7)
Action Research Arm Test (ARAT) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	25.3 (16.8)
Jebsen-Taylor Hand Function Test (JTHFT) (items completed per second) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [items completed per second]	1.046 (0.930)
NIH Stroke Scale (NIHSS) (score on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [score on a scale]	3.4 (1.4)
Grip Strength (kilograms of force) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms of force]	11.13 (8.7)
Pinch Strength (kilograms of force) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms of force]	4.48 (2.3)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	37.8 (11.7)
Immediately after end of treatment (within a week)	41.3 (11.9)
2 weeks after end of treatment	47 (10.5)
12 weeks after end of treatment	41.3 (12.9)

2. Primary Outcome

Title	Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	-1.49 (1.61)
Immediately after end of treatment (within a week)	-1.66 (1.53)

3. Primary Outcome

Title	Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	486.10 (92.56)
Immediately after end of treatment (within a week)	459.90 (109.60)

4. Primary Outcome

Title	Movement Quality as Assessed by Exoskeleton Kinematics - Average Speed
Description	A higher value indicates better movement quality.
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	15.80 (8.28)
Immediately after end of treatment (within a week)	20.08 (7.29)

5. Primary Outcome

Title	Movement Quality as Assessed by Exoskeleton Kinematics - Spectral Arc Length
Description	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).
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	-2.64 (0.95)
Immediately after end of treatment (within a week)	-2.29 (0.47)

6. Primary Outcome

Title	Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Description	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).
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	2.13 (0.76)
Immediately after end of treatment (within a week)	1.78 (0.81)

7. Primary Outcome

Title	Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	0.35 (0.14)
Immediately after end of treatment (within a week)	0.43 (0.16)

8. Secondary Outcome

Title	Score on Action Research Arm Test (ARAT)
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	25.30 (16.80)
Immediately after end of treatment (within a week)	30.50 (20.89)
2 weeks after end of treatmen	34.71 (17.16)
12 weeks after end of treatment	30.33 (21.49)

9. Secondary Outcome

Title	Score on Jebsen-Taylor Hand Function Test (JTHFT)
Description	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.
Time Frame	Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	1.05 (0.93)
Immediately after end of treatment (within a week)	1.00 (0.88)
2 weeks after end of treatment	1.32 (0.86)
12 weeks after end of treatment	1.11 (0.88)

10. Secondary Outcome

Title	Grip Strength
Description	A grip dynamometer will be used to measure maximum gross grasp force.
Time Frame	Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	11.13 (8.70)
Immediately after end of treatment (within a week)	12.64 (9.91)
2 weeks after end of treatment	13.33 (9.19)
12 weeks after end of treatment	12.26 (9.42)

11. Secondary Outcome

Title	Pinch Strength
Description	A pinch gauge will be used to measure maximum pinch force.
Time Frame	Baseline, immediately after end of treatment (within a week), 2 weeks after end of treatment, 12 weeks after end of treatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
Measure Participants	10
Baseline	4.48 (2.29)
Immediately after end of treatment (within a week)	5.01 (2.53)
2 weeks after end of treatment	5.47 (1.30)
12 weeks after end of treatment	4.55 (1.45)

Adverse Events

Time Frame	2 months
Arm/Group Title	BMI Control of MAHI Exo-II
Arm/Group Description	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.
All Cause Mortality
	BMI Control of MAHI Exo-II
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	BMI Control of MAHI Exo-II
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	BMI Control of MAHI Exo-II
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

Absence of control group, low sample size

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.