- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05560867
Neural Mechanisms of Motor Recovery With Technology Assisted Training
Neural Mechanisms of Motor Recovery With Technology Assisted Training for Post-stroke Hemiparesis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Description: This study will investigate the neural mechanisms of technology-assisted-training for post-stroke hemiparesis by using functional near-infrared-spectroscopy (fNIRS). Patients with hemiparesis affecting the arm will be brought in for 3 weeks of technology-assisted-training while having fNIRS recordings of their brain activity. Analysis of these brain activation patterns will help determine what areas of the brain are necessary to respond to this type of training.
Objectives: 1) to investigate brain network activity changes that occur during technology-assisted-training and 2) to determine the baseline residual brain network connectivity required for patients to respond to robot-assisted-training.
Endpoints: The study will evaluate increases in cortical connectivity between bilateral primary motor areas, angular gyrus and parietal operculum to test the hypothesis that cortical connectivity in these areas will positively correlate with improvement in technology-assisted-assessments. The study will also assess baseline connectivity of the angular gyrus and parietal operculum to sensorimotor networks to test the hypothesis that cortical connectivity in these areas will predict reductions in arm motor impairments that occur with technology-assisted-training.
Study Population: Patients of either gender with chronic (at least 6 months or more) hemiparesis of the arm caused by a single unilateral stroke will be recruited from Baltimore city and the surrounding counties.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland
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Contact:
- Director, Brain Rehab and Recovery Lab
- Phone Number: 410-448-6763
- Email: rbraun@som.umaryland.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 88 years
- Able to provide informed consent based on Evaluation to Sign Informed Consent.
- History of clinically defined, unilateral hemiparetic stroke, with radiologic exclusion of other possible diagnosis, causing weakness in 1 arm 6 months or more prior to enrollment.
- Fugl-Meyer upper extremity score <= 50 at time of enrollment
- Medically stable to participate in the study and have mobility, visual, and cognitive abilities sufficient to follow directions and engage in the gamified therapeutic tasks.
Exclusion Criteria:
- Undergoing any significant medical treatments requiring regular visits, treatments, or therapies at the time of enrollment or anytime during the study.
- Hair or scalp implant that would not allow near infrared spectroscopy probes to sit on scalp.
- Injection of botulinum toxin to the paretic arm within 3 months of enrollment or during the study or injection of daxibotulinumtoxinA within 6 months of enrollment or during the study
- Orthopedic, rheumatologic, or other medical disease that would make the procedures of participation dangerous, painful, or uncomfortable.
- Contraindications to MRI, including intracranial magnetic items, implanted pumps, pacemakers, or stimulators, or claustrophobia.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient Robot-Assisted Training Group
Patients will undergo robot-assisted physical therapy three times a week, for a total of 9 sessions, while functional near-infrared spectroscopy data is collected.
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These training platforms use gamified training tasks to improve motor control in the hemiparetic arm
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in cortical connectivity measures as assessed using MRI
Time Frame: Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
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Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.
MRI sequences include T1 MPRAGE, BOLD (T2*), FLAIR T2, ASL, and DTI.
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Baseline MRI will be collected at the time of study enrollment (for a total of up to 4 weeks during study enrollment)
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Changes in cortical connectivity measures as assessed using fNIRS
Time Frame: Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Cortical connectivity is assessed between bilateral primary motor areas, angular gyrus and parietal operculum.
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Baseline fNIRS collected at the time of study enrollment, with repeated fNIRS measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in arm kinematics (position)
Time Frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Arm kinematics measures of position collected by the rehabilitation training technology devices
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Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in arm kinematics (velocity)
Time Frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Arm kinematics measures of velocity collected by the rehabilitation training technology devices
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Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in arm kinematics (acceleration)
Time Frame: Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Arm kinematics measures of acceleration collected by the rehabilitation training technology devices
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Baseline kinematics at the time of study enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in Fugl-Myer Scores for the Upper Extremity ("FM-UE")
Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Standardized bedside test examining the degree of motor impairment for the arm/hand.
Scores range from 0 - 66 with higher scores representing better recovery.
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At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in Action Research Arm Test
Time Frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
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Standardized bedside test examining behavioral tasks for the arm/hand.
Scores range from 0-57 points, with a maximum score of 57 points indicating better performance.
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At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
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Changes in Wolf Motor Function Test ("WMFT")
Time Frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
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Standardized bedside test examining behavioral tasks for the arm/hand.
Score Ranges Minimum 0 to Maximum 75; Lower scores are indicative of lower functioning levels.
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At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment).
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Changes in Shoulder Abduction Finger Extension ("SAFE") score
Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Standardized bedside test examining strength of the arm/hand.
Scores range from 0-10 with higher scores representing better strength.
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At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in NIH Stroke Scale Score ("NIHSS")
Time Frame: At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Standardized bedside test to assess stroke symptoms.
Scores range from 0 - 42, where higher scores indicate greater symptom severity.
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At the time of enrollment with repeated measures at each therapy treatment session (for a total of up to 4 weeks during study enrollment)
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Changes in Stroke Impact Scale ("SIS")
Time Frame: At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment)
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Standardized questionnaire examining patient perceptions of how stroke impacts their function and quality of life.
Scores range from 0 to 100 with higher scores indicating a higher quality of life.
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At the time of enrollment (pre-training) with a second measure at the final study session (post-training) (for a total of up to 4 weeks during study enrollment)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00093740
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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