Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-07 @ 6:57 AM
Study NCT ID:
NCT03300258
Status:
TERMINATED
Last Update Posted:
2023-10-05
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Robotic Pedaling Therapy for Targeted Neural Plasticity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'peter.adamczyk@wisc.edu', 'phone': '(608) 263-3231', 'title': 'Peter Adamczyk', 'organization': 'University of Wisconsin, Madison'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Six Minute Walk Test (6MWT) Distance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple series of laps along a 30 m straight path in a level hallway.', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'fMRI scans will be used to measure task-specific cortical activity in sensorimotor areas during physical stepping with an MRI-compatible stepping machine, or imagined/visualized cycling.', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Timed Up-and-Go Test (TUG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple timed test of how long it takes to stand up, walk 10 feet, turn around, return to the starting point, and sit down.', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Self-Selected Walking Speed (SSWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple test of the speed a person chooses to walk over a 5-meter distance', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Fastest Comfortable Walking Speed (FCWS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'SECONDARY', 'title': 'Change in Center of Pressure (COP) Characteristics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'OG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'OG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'OG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'timeFrame': 'Baseline and at 5 weeks', 'description': 'Movement of the Center of Pressure during standing, with eyes open and eyes closed. With eyes open, subjects focus their eyes on a spot on the wall in front of them. Metrics of COP control include excursion, average velocity, standard deviation, and an estimate of center of mass location.', 'reportingStatus': 'POSTED', 'populationDescription': 'Healthy Pilot Group participants were enrolled and the study team learned that the protocol was insufficient to test the hypothesis. No data were collected for this measure.'}, {'type': 'POST_HOC', 'title': 'Reaction Time in "Medium" Catch Trials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Reaching against a Spring-Like Torque experiment'}], 'classes': [{'title': 'Train High, Catch Medium', 'categories': [{'measurements': [{'value': '0.366', 'spread': '0.038', 'groupId': 'OG000'}]}]}, {'title': 'Train Low, Catch Medium', 'categories': [{'measurements': [{'value': '0.375', 'spread': '0.037', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 visit roughly 3 hours', 'description': 'The test involved reaching against spring-like torque, where the spring stiffness was mostly constant but was changed unexpectedly by the computer in different trials. Reaction time definition: time from a visual and auditory cue to initial movement.\n\nParticipants were "Trained" with mostly a Low or High stiffness (each in a separate block of reaches) and had "Catch" trials when the stiffness was changed to Medium.\n\n"Low" stiffness = 10 Newton meter per radian (Nm/rad); "Medium" stiffness = 20 Nm/rad; "High" stiffness = 30 Nm/rad', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}, {'type': 'POST_HOC', 'title': 'Movement Settling Time: Reaching Against a Spring-Like Torque', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Reaching against a Spring-Like Torque experiment'}], 'classes': [{'title': '"high" stiffness training', 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.068', 'groupId': 'OG000'}]}]}, {'title': '"low" stiffness training', 'categories': [{'measurements': [{'value': '1.24', 'spread': '0.071', 'groupId': 'OG000'}]}]}, {'title': '"catch medium" trials when training was "high"', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.079', 'groupId': 'OG000'}]}]}, {'title': '"catch medium" trials when training was "low"', 'categories': [{'measurements': [{'value': '1.40', 'spread': '0.096', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 visit roughly 3 hours', 'description': 'The test involved reaching against spring-like torque, where the spring stiffness was mostly constant but was changed unexpectedly by the computer in different trials. Movement Settling Time definition: time for crank angle to settle between 40 and 50 degrees, when the central target was 45 degrees.\n\n"Low" stiffness = 10 Nm/rad; "Medium" stiffness = 20 Nm/rad; "High" stiffness = 30 Nm/rad\n\n"Catch trials" are unexpected medium stiffness setting, unpredictably spaced.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}, {'type': 'POST_HOC', 'title': 'Undershoot and Overshoot in Catch Trials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1', 'description': 'Reaching against a Spring-Like Torque experiment'}], 'classes': [{'title': 'Undershoot', 'categories': [{'measurements': [{'value': '37.3', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Overshoot', 'categories': [{'measurements': [{'value': '52.4', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 visit roughly 3 hours', 'description': 'The test involved reaching against spring-like torque, where the spring stiffness was mostly constant but was changed unexpectedly by the computer in different trials. All participants had a block with "Low" training, called "Train Low Catch Medium", and a separate block with "High" training, called "Train High Catch Medium".\n\nUndershoot: initial reach showed undershoot relative to the target crank angle of 45 degrees, with the value measured as the local minimum as the pedal momentarily stopped and went backward.\n\nOvershoot: initial reach showed overshoot beyond the target crank angle of 45 degrees, with the value measured as the maximum angle during that period.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}, {'type': 'POST_HOC', 'title': 'Movement Settling Time: Reaching Against a Damper-Like Force', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Reaching against a damper-like force experiment'}], 'classes': [{'title': 'high damping', 'categories': [{'measurements': [{'value': '1.21', 'spread': '0.040', 'groupId': 'OG000'}]}]}, {'title': 'low damping', 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.056', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 visit roughly 3 hours', 'description': 'The test involved reaching against viscous damper torque, where the damping constant (units: Nm/(rad/s) = torque produced by the robot per rad/s of crank velocity) was changed by the computer in a structured but unpredictable sequence, across the trials. Movement settling time is defined as time for crank angle to settle between 40 and 50 degrees, when the central target was 45 degrees.\n\nLow damping = 3 Nm/(rad/s), High damping = 9 Nm/(rad/s).', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}, {'type': 'POST_HOC', 'title': 'Movement Settling Time With Damping Level Cued Visually', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2', 'description': 'Reaching against a damper-like force experiment'}], 'classes': [{'title': 'High Damping Cued Visually', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.041', 'groupId': 'OG000'}]}]}, {'title': 'Low Damping Cued Visually', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.030', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 visit roughly 3 hours', 'description': 'The test involved reaching against viscous damper torque, where the damping constant (units: Nm/(rad/s) = torque produced by the robot per rad/s of crank velocity) was changed by the computer in a structured but unpredictable sequence, across the trials. Movement settling time is defined as time for crank angle to settle between 40 and 50 degrees, when the central target was 45 degrees. In this experiment, the damping level was visually cued. Low damping = 3 Nm/(rad/s), High damping = 9 Nm/(rad/s)', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}, {'type': 'POST_HOC', 'title': 'Number of Participants Who Completed the Half-Reversed Cycling Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 3', 'description': 'Half-Reversed Cycling Task'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Five training sessions of 45 minutes, each on a different day within roughly one week. Additionally, a 6th session with the effects of the two pedals switched', 'description': 'The effect of pushing on one specific pedal was reversed by the computer in its calculation of how to move the crank; the other pedal had a physically typical effect. The task was to cause this complex system to move the crank at a constant 20 RPM forward speed (i.e., minimize the error in speed from this target). Reported here are the number of participants who completed this task.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted. Summary Data collected from experimental tasks in development are reported here as post-hoc outcomes.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}, {'id': 'FG001', 'title': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy\n\nHealthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.'}, {'id': 'FG002', 'title': 'Robotic Training Group', 'description': 'Robotic therapy\n\nSubjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.'}, {'id': 'FG003', 'title': 'Aerobic Training Group', 'description': 'Aerobic therapy.\n\nSubjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Group 1: Reaching Against a Spring-Like Torque', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Group 2: Reaching Against a Damper-like Force', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Group 3: Half-Reversed Cycling Task', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy participants were recruited from June 2019 to June 2022.', 'preAssignmentDetails': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population. A clinical trial was not conducted.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy and Aerobic therapy\n\nSubjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-14', 'size': 364441, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-12T12:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-03', 'studyFirstSubmitDate': '2017-06-12', 'resultsFirstSubmitDate': '2023-08-15', 'studyFirstSubmitQcDate': '2017-09-27', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-03', 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Six Minute Walk Test (6MWT) Distance', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple series of laps along a 30 m straight path in a level hallway.'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'fMRI scans will be used to measure task-specific cortical activity in sensorimotor areas during physical stepping with an MRI-compatible stepping machine, or imagined/visualized cycling.'}, {'measure': 'Change in Timed Up-and-Go Test (TUG)', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple timed test of how long it takes to stand up, walk 10 feet, turn around, return to the starting point, and sit down.'}, {'measure': 'Change in Self-Selected Walking Speed (SSWS)', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A simple test of the speed a person chooses to walk over a 5-meter distance'}, {'measure': 'Change in Fastest Comfortable Walking Speed (FCWS)', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance'}, {'measure': 'Change in Center of Pressure (COP) Characteristics', 'timeFrame': 'Baseline and at 5 weeks', 'description': 'Movement of the Center of Pressure during standing, with eyes open and eyes closed. With eyes open, subjects focus their eyes on a spot on the wall in front of them. Metrics of COP control include excursion, average velocity, standard deviation, and an estimate of center of mass location.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The aim of this Pilot study is to determine whether robotically targeted lower-limb pedaling therapy can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Forty (40) adult stroke patients and 80 healthy controls will be enrolled in this study. Of the 40 patients, half will be randomly assigned to the robotically-targeted training ("robotic") group and will receive training on the targeted training task. The other half of the patients will perform a duration-matched aerobic pedaling exercise ("control" group). All stroke patients will be scanned before and after their training program while performing or imagining simple motor tasks. Behavioral assessments of motor and cognitive capacities will be collected at each timepoint. Healthy control subjects enrolled for device testing (20) will receive up to 5 training sessions in a modified robotic paradigm and 1 fMRI scan, in order to investigate motor learning and brain activity in a novel motor control task. Additional healthy pilot subjects (up to 60) will test training protocols and assessments during preparatory design phases of the project.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients:\n\nInclusion criteria:\n\n* Subjects will be stroke patients with persistent moderate unilateral lower extremity deficits, age 50-85 years at time of enrollment.\n* Time since stroke will be greater than 6 months ("chronic" stroke survivors).\n* Persistent moderate unilateral lower-limb impairment (defined as NIH Stroke Scale - Motor Leg section score of 1-2, to be discussed with the patient verbally during phone screening and assessed by the investigator during the initial enrollment visit).\n* Fluent in spoken and written English\n\nExclusion criteria:\n\n* Allergy to electrode gel, surgical tape and metals.\n* Subjects under treatment for infectious diseases will be excluded from the study.\n* Women who are pregnant or planning to become pregnant during the course of the study will be excluded.\n* Contraindications for MRI\n* Age over 85 years at time of enrollment.\n\nHealthy Controls:\n\nInclusion criteria:\n\n* Ages 18-85 years\n* Non-Stroke Group 1 ("Matched Controls"): 50-85 years old at time of enrollment, to match the population of stroke patients to be studied\n* Non-Stroke Group 2 ("Pilot Controls"): 18-50 years old at time of enrollment (Pilot subjects to be initially enrolled early in the design phase of the study, and with enrollment ongoing throughout the study to continue development.)\n* No known neurologic, psychiatric or developmental disability.\n* Fluent in spoken and written English\n\nExclusion criteria:\n\n* Allergy to electrode gel, surgical tape, and metals.\n* Subjects under treatment for infectious diseases will be excluded from the study.\n* Women who are pregnant or planning to become pregnant during the course of the study will be excluded.\n* Contraindications for MRI\n* Age over 85 years at time of enrollment.'}, 'identificationModule': {'nctId': 'NCT03300258', 'briefTitle': 'Robotic Pedaling Therapy for Targeted Neural Plasticity', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Robotic Pedaling Therapy for Targeted Neural Plasticity', 'orgStudyIdInfo': {'id': '2016-1279'}, 'secondaryIdInfos': [{'id': 'A196200', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'ENGR\\MECHANICAL ENGR', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 1.8, 3/2017', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '4UL1TR000427-10', 'link': 'https://reporter.nih.gov/quickSearch/4UL1TR000427-10', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Non-Stroke Pilot Group', 'description': 'Robotic therapy. Aerobic therapy. Subjects without stroke, pilot subjects tested during early phases while the device and therapeutic task specifications are developed, and throughout the project while the device and tasks are refined.', 'interventionNames': ['Device: Robotic therapy', 'Device: Aerobic therapy']}, {'type': 'OTHER', 'label': 'Non-Stroke Comparison Group', 'description': 'Robotic therapy. Healthy controls enrolled (age 50-85) to contribute to a normative data set on motor learning using the robotic protocols designed for stroke.', 'interventionNames': ['Device: Robotic therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Robotic Training Group', 'description': 'Robotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.', 'interventionNames': ['Device: Robotic therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Training Group', 'description': 'Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.', 'interventionNames': ['Device: Aerobic therapy']}], 'interventions': [{'name': 'Robotic therapy', 'type': 'DEVICE', 'description': 'The "Robotic" group will use a robotic training protocol to incentivize recovery of motor control by changing task demands throughout the training period. One or more target tasks will be chosen to mimic different sub-functions of gait, including some which are not normally excited in typical cycling behavior. Also, tasks may be designed to target non-gait motions such as hip ab/adduction. The required task may be changed periodically. This therapy protocol will occupy 30 minutes of each training session. Prior to testing, EMG electrodes will be placed on the major muscles of both legs, a procedure that takes roughly 15 minutes. Another 15 minutes is for changing clothes, briefing the subject, and other ancillary study activities. The total time per training session is 1 hour.', 'armGroupLabels': ['Non-Stroke Comparison Group', 'Non-Stroke Pilot Group', 'Robotic Training Group']}, {'name': 'Aerobic therapy', 'type': 'DEVICE', 'description': "The Control group protocol is identical to that of the Robotic group, except the robotically-incentivized exercise is replaced with an aerobic exercise. This intervention emulates a commercial motorized exercise bike to improve cardiovascular unfitness contributions to gait impairment. This therapy implements assist-as-needed and constant-velocity control. The patient's target pedaling speed (e.g. 20 rev/min (to be finalized through pilot tests) and power level (set by heart rate to require approximately 50-70% of maximal oxygen uptake) are set at the beginning of each session and a motor provides assistance or resistance to compensate for the performance of the patient. The exercise will be performed in this mode for 30 minutes per training session.", 'armGroupLabels': ['Aerobic Training Group', 'Non-Stroke Pilot Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53706', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin, Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Peter G Adamczyk, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}