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| ID | Type | Description | Link |
|---|---|---|---|
| A196200 | Other Identifier | UW Madison | |
| ENGR\MECHANICAL ENGR | Other Identifier | UW Madison | |
| Protocol Version 1.8, 3/2017 | Other Identifier | UW Madison | |
| 4UL1TR000427-10 | U.S. NIH Grant/Contract | View source |
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Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Stroke Pilot Group | Other | 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. |
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| Non-Stroke Comparison Group | Other | 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. |
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| Robotic Training Group | Experimental | Robotic therapy. Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle. |
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| Aerobic Training Group | Active Comparator | Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Six Minute Walk Test (6MWT) Distance | A simple series of laps along a 30 m straight path in a level hallway. | Baseline and at 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI) | 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. | Baseline and at 5 weeks |
| Change in Timed Up-and-Go Test (TUG) |
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Patients:
Inclusion criteria:
Exclusion criteria:
Healthy Controls:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter G Adamczyk, Ph.D. | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53706 | United States |
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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.
Healthy participants were recruited from June 2019 to June 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Stroke Pilot Group | Robotic therapy and 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. |
| FG001 | Non-Stroke Comparison Group | 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. |
| FG002 | Robotic Training Group | Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle. |
| FG003 | Aerobic Training Group | Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Stroke Pilot Group | Robotic therapy and 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Six Minute Walk Test (6MWT) Distance | A simple series of laps along a 30 m straight path in a level hallway. | 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. | Posted | Baseline and at 5 weeks |
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up to 1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Stroke Pilot Group | Robotic therapy and 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. |
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Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Adamczyk | University of Wisconsin, Madison | (608) 263-3231 | peter.adamczyk@wisc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2017 | Sep 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Aerobic therapy | Device | 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. |
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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. |
| Baseline and at 5 weeks |
| Change in Self-Selected Walking Speed (SSWS) | A simple test of the speed a person chooses to walk over a 5-meter distance | Baseline and at 5 weeks |
| Change in Fastest Comfortable Walking Speed (FCWS) | A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance | Baseline and at 5 weeks |
| Change in Center of Pressure (COP) Characteristics | 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. | Baseline and at 5 weeks |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Robotic Training Group | Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle. |
| OG003 | Aerobic Training Group | Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group. |
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| Secondary | Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI) | 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. | 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. | Posted | Baseline and at 5 weeks |
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| Secondary | Change in Timed Up-and-Go Test (TUG) | 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. | 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. | Posted | Baseline and at 5 weeks |
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| Secondary | Change in Self-Selected Walking Speed (SSWS) | A simple test of the speed a person chooses to walk over a 5-meter distance | 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. | Posted | Baseline and at 5 weeks |
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| Secondary | Change in Fastest Comfortable Walking Speed (FCWS) | A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance | 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. | Posted | Baseline and at 5 weeks |
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| Secondary | Change in Center of Pressure (COP) Characteristics | 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. | 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. | Posted | Baseline and at 5 weeks |
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| Post-Hoc | Reaction Time in "Medium" Catch Trials | 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. Participants 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. "Low" stiffness = 10 Newton meter per radian (Nm/rad); "Medium" stiffness = 20 Nm/rad; "High" stiffness = 30 Nm/rad | 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. | Posted | Mean | Standard Deviation | seconds | 1 visit roughly 3 hours |
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| Post-Hoc | Movement Settling Time: Reaching Against a Spring-Like Torque | 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. "Low" stiffness = 10 Nm/rad; "Medium" stiffness = 20 Nm/rad; "High" stiffness = 30 Nm/rad "Catch trials" are unexpected medium stiffness setting, unpredictably spaced. | 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. | Posted | Mean | Standard Deviation | seconds | 1 visit roughly 3 hours |
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| Post-Hoc | Undershoot and Overshoot in Catch Trials | 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". Undershoot: 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. Overshoot: initial reach showed overshoot beyond the target crank angle of 45 degrees, with the value measured as the maximum angle during that period. | 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. | Posted | Mean | Standard Deviation | degrees | 1 visit roughly 3 hours |
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| Post-Hoc | Movement Settling Time: Reaching Against a Damper-Like Force | 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. Low damping = 3 Nm/(rad/s), High damping = 9 Nm/(rad/s). | 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. | Posted | Mean | Standard Deviation | seconds | 1 visit roughly 3 hours |
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| Post-Hoc | Movement Settling Time With Damping Level Cued Visually | 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) | 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. | Posted | Mean | Standard Deviation | seconds | 1 visit roughly 3 hours |
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| Post-Hoc | Number of Participants Who Completed the Half-Reversed Cycling Task | 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. | 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. | Posted | Count of Participants | Participants | 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 |
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| 44 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| "catch medium" trials when training was "low" |
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