StrokeNeuroExoNCT05374486
EEG Brain-Machine Interface Control of an Upper-Limb Robotic Exoskeleton for Robot-Assisted Rehabilitation After Stroke
A study testing NeuroExo co-robot neurorehabilitation system in people with Stroke and Hemiparesis, run by University of Houston at 3 sites in United States.
Trial summary
The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- NeuroExo co-robot neurorehabilitation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 25 Apr 2022to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects between the ages of 20-65, male or female,
- mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
- the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
- Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
- Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
- Patients will have to have normal/near normal strength in one upper/lower extremity and appreciable weakness in the other upper/lower extremity.
Who cannot join
- history of traumatic brain injury prior to the current episode,
- Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
- Women and minorities will be recruited as long as they meet the inclusion criteria.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
The Institute for Rehabilitation and Research (TIRR) at Memorial Hermann
Houston, Texas, 77030
Shuo-Hsiu "James" Chang, PhD, 713-799-7016, shuo-hsiu.chang@uth.tmc.edu
- Recruiting
TIRR Memorial Hermann Hospital
Houston, Texas, 77056
Gerard E Francisco, MD, 713-797-5244, gerard.e.francisco@uth.tmc.edu
Shuo-Hsiu Chang, PT, PhD, 713-799-7016, Shuo-Hsiu.Chang@uth.tmc.edu
- Recruiting
University of Houston
Houston, Texas, 77204
Jose L Contreras-Vidal, PhD, 713-743-4429, jlcontreras-vidal@uh.edu
Jose L Contreras-Vidal, PhD
About this study
Official title: PFI-RP: Smart Co-robot System for Cost-Effective Patient-Centered Robotic Rehabilitation
The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.
The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .
The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.
Read the detailed description
This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.
- Conditions
- Stroke, Hemiparesis
- Being tested
- NeuroExo co-robot neurorehabilitation system
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroExo co-robot neurorehabilitation systemDevice
Also called Brain-Machine Interface, Brain-Computer Interface, Neurorobotics, Rehabilitation Robotics
In this longitudinal study, adult subjects with hemiparesis due to chronic stroke will receive robotic-assisted upper-arm training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG). After one screening visit, two baseline visits for EEG signal screens, six onsite training sessions will be provided with the NeuroExo system, followed by 60 home therapy sessions (2 sessions per day, 5 days per week for 6 weeks). If the participant have completed at least 50 sessions of neurotherapy at home, the participant will complete a set of measurements to assess function of the affected upper arm and brain activity within 3 days after the last session for post-assessment visit, and one-month post follow-up session. The total amount of time for this study is 16-20 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NeuroExo | Experimental | NeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance. Receives: Device: NeuroExo co-robot neurorehabilitation system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
EEG activity in the delta, theta, alpha, beta and gamma bands 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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Movement Quality as Assessed by Exoskeleton Kinematics
A higher value indicates better movement quality.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
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).
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Secondary outcomes (4)
Score on Action Research Arm Test (ARAT)
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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Score on Jebsen-Taylor Hand Function Test (JTHFT)
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.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Grip Strength
A grip dynamometer will be used to measure maximum gross grasp force.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Pinch Strength
A pinch gauge will be used to measure maximum pinch force.
Measured: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start25 Apr 2022
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Jose L.Contreras-Vidal, Ph.D., University of Houston
- Investigators
- Jose L Contreras-Vidal, PhD, Principal investigator, University of HoustonGerard Francisco, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374486
- Sponsor's protocol ID
- G0501521
- Other IDs
- HSC-MS-20-1287
- Acronym
- NeuroExo
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to make IPD available to other researchers.
Publications
Bhagat NA, Yozbatiran N, Sullivan JL, Paranjape R, Losey C, Hernandez Z, Keser Z, Grossman R, Francisco GE, O'Malley MK, Contreras-Vidal JL. Neural activity modulations and motor recovery following brain-exoskeleton interface mediated stroke rehabilitation. Neuroimage Clin. 2020;28:102502. doi: 10.1016/j.nicl.2020.102502. Epub 2020 Nov 19.
PubMed 33395991Sullivan JL, Bhagat NA, Yozbatiran N, Paranjape R, Losey CG, Grossman RG, Contreras-Vidal JL, Francisco GE, O'Malley MK. Improving robotic stroke rehabilitation by incorporating neural intent detection: Preliminary results from a clinical trial. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:122-127. doi: 10.1109/ICORR.2017.8009233.
PubMed 28813805Bhagat 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.
PubMed 27065787Bhagat 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.
PubMed 25570900Venkatakrishnan A, Francisco GE, Contreras-Vidal JL. Applications of Brain-Machine Interface Systems in Stroke Recovery and Rehabilitation. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):93-105. doi: 10.1007/s40141-014-0051-4.
PubMed 25110624
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFI-RP: Smart Co-robot System for Cost-Effective Patient-Centered Robotic Rehabilitation
- ClinicalTrials.gov ID
- NCT05374486
- Acronym / sponsor ID
- NeuroExo / G0501521
- Conditions
- Stroke, Hemiparesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- TIRR Memorial Hermann, The University of Texas Health Science Center, Houston
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to develop a clinically feasible, low-cost, nonsurgical neurorobotic system for restoring function to motor-impaired stroke survivors that can be used at the clinic or at home. Moreover, another goal is to understand how physical rehabilitation assisted by robotic device combined with electroencephalograph (EEG) can benefit adults who have had stroke to improve functions of their weaker arm.
The proposed smart co-robot training system (NeuroExo) is based on a physical upper-limb robotic exoskeleton commanded by a non-invasive brain machine interface (BMI) based on scalp EEG to actively include the participant in the control loop .
The study will demonstrate that the Neuroexo smart co-robot arm training system is feasible and effective in improving arm motor functions in the stroke population for their use at home.The NeuroExo study holds the promise to be cost-effective patient-centered neurorehabilitation system for improving arm functions after stroke.
Detailed description
This study has two phases: The first phase will consist of baseline recordings for system calibration and training sessions to be conducted in a clinical setting. The second phase will consist of NeuroExo BMI-exo neurotherapy to be conducted at the participant's home. Throughout the study and after completion of the study, movement and brain activity will be analyzed to assess function of the affected upper extremity and changes in brain activity associated with the neurotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NeuroExo | Experimental | Device: NeuroExo co-robot neurorehabilitation systemNeuroExo is a device which includes a robotic exoskeleton that you were in your affected arm to assist you with arm movements, a headset that you wear on your head to measure your brain activity and detect your intention to move, and a graphical user interface that allows you to initiate and stop neurotherapy, and track your motor performance. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subjects between the ages of 20-65, male or female,
- mild-to- moderate unilateral stroke confirmed by brain CT or MRI scan and manifested by a Glasgow Coma scale (GCS) score between 15 and 9 documented within 6 months,
- the ability to perform 20deg of active wrist/elbow for upper limb robotic movement on the affected side, no planned alteration in lower/upper- extremity therapy/medication for muscle tone during course of study,
- Anticipated length of needed acute interdisciplinary rehabilitation of 30 days or more.
- Patients are required to have a MMSE>=24 to rule out those with cognitive impairments.
Key exclusion criteria (3 listed)
- history of traumatic brain injury prior to the current episode,
- Severe neurologic or psychiatric condition preventing participation in rehabilitation and physical therapy activities (patients unable or unwilling to receive instruction and effectively complete a simple assigned task as determined by MMSE>=24 specified in inclusion criteria).
- Women and minorities will be recruited as long as they meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroExo co-robot neurorehabilitation systemAlso: Brain-Machine Interface, Brain-Computer Interface, Neurorobotics, Rehabilitation RoboticsIn this longitudinal study, adult subjects with hemiparesis due to chronic stroke will receive robotic-assisted upper-arm training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG). After one screening visit, two baseline visits for EEG signal screens, six onsite training sessions will be provided with the NeuroExo system, followed by 60 home therapy sessions (2 sessions per day, 5 days per week for 6 weeks). If the participant have completed at least 50 sessions of neurotherapy at home, the participant will complete a set of measurements to assess function of the affected upper arm and brain activity within 3 days after the last session for post-assessment visit, and one-month post follow-up session. The total amount of time for this study is 16-20 weeks. | Device | NeuroExo |
Primary outcome
Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score
Time frame: Baseline, immediately after end of treatment (within a week), and 4 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.
Neural Activity (Cortical Dynamics) Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Amplitude
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
EEG activity in the delta, theta, alpha, beta and gamma bands 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.
Cortical Dynamics Measured by Electroencephalography (EEG) Movement-related Cortical Potential (MRCP) Latency
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
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.
Movement Quality as Assessed by Exoskeleton Kinematics
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
A higher value indicates better movement quality.
Movement Quality as Assessed by Exoskeleton Kinematics - Number of Peaks
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
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).
Movement Quality as Assessed by Exoskeleton Kinematics - Time to First Peak
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
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.
4 secondary outcomes
Score on Action Research Arm Test (ARAT)
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Score on Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Grip Strength
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Pinch Strength
Time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Background: PubMed 33395991Bhagat NA, Yozbatiran N, Sullivan JL, Paranjape R, Losey C, Hernandez Z, Keser Z, Grossman R, Francisco GE, O'Malley MK, Contreras-Vidal JL. Neural activity modulations and motor recovery following brain-exoskeleton interface mediated stroke rehabilitation. Neuroimage Clin. 2020;28:102502. doi: 10.1016/j.nicl.2020.102502. Epub 2020 Nov 19.
- Background: PubMed 28813805Sullivan JL, Bhagat NA, Yozbatiran N, Paranjape R, Losey CG, Grossman RG, Contreras-Vidal JL, Francisco GE, O'Malley MK. Improving robotic stroke rehabilitation by incorporating neural intent detection: Preliminary results from a clinical trial. IEEE Int Conf Rehabil Robot. 2017 Jul;2017:122-127. doi: 10.1109/ICORR.2017.8009233.
- Background: PubMed 27065787Bhagat 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.
- Background: PubMed 25570900Bhagat 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.
- Background: PubMed 25110624Venkatakrishnan A, Francisco GE, Contreras-Vidal JL. Applications of Brain-Machine Interface Systems in Stroke Recovery and Rehabilitation. Curr Phys Med Rehabil Rep. 2014 Jun 1;2(2):93-105. doi: 10.1007/s40141-014-0051-4.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose L Contreras-Vidal, PhD principal investigator
University of Houston
Gerard Francisco, MD principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroExo co-robot neurorehabilitation system in people with Stroke and Hemiparesis, run by University of Houston at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (713 799 7016, shuo-hsiu.chang@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Fugl-Meyer Arm (FMA) Motor Score (time frame: Baseline, immediately after end of treatment (within a week), and 4 weeks after end of treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05374486, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.