Trial Outcomes & Findings for Robotic Pedaling Therapy for Targeted Neural Plasticity (NCT NCT03300258)

NCT ID: NCT03300258

Last Updated: 2023-10-05

Results Overview

A simple series of laps along a 30 m straight path in a level hallway.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 44 participants
• Primary outcome timeframe: Baseline and at 5 weeks
• Results posted on: 2023-10-05

Participant Flow

Healthy participants were recruited from June 2019 to June 2022.

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.

Participant milestones

Measure	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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Overall Study STARTED	44	0	0	0
Overall Study Group 1: Reaching Against a Spring-Like Torque	12	0	0	0
Overall Study Group 2: Reaching Against a Damper-like Force	11	0	0	0
Overall Study Group 3: Half-Reversed Cycling Task	21	0	0	0
Overall Study COMPLETED	44	0	0	0
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic Pedaling Therapy for Targeted Neural Plasticity

Baseline characteristics by cohort

Measure	Non-Stroke Pilot Group n=44 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

A simple series of laps along a 30 m straight path in a level hallway.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

A simple test of the speed a person chooses to walk over a 5-meter distance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and at 5 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: 1 visit roughly 3 hours

Population: 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.

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

Outcome measures

Measure	Non-Stroke Pilot Group n=12 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Reaction Time in "Medium" Catch Trials Train High, Catch Medium	0.366 seconds Standard Deviation 0.038	—	—	—
Reaction Time in "Medium" Catch Trials Train Low, Catch Medium	0.375 seconds Standard Deviation 0.037	—	—	—

POST_HOC outcome

Timeframe: 1 visit roughly 3 hours

Population: 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.

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.

Outcome measures

Measure	Non-Stroke Pilot Group n=12 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Movement Settling Time: Reaching Against a Spring-Like Torque "high" stiffness training	1.21 seconds Standard Deviation 0.068	—	—	—
Movement Settling Time: Reaching Against a Spring-Like Torque "low" stiffness training	1.24 seconds Standard Deviation 0.071	—	—	—
Movement Settling Time: Reaching Against a Spring-Like Torque "catch medium" trials when training was "high"	1.29 seconds Standard Deviation 0.079	—	—	—
Movement Settling Time: Reaching Against a Spring-Like Torque "catch medium" trials when training was "low"	1.40 seconds Standard Deviation 0.096	—	—	—

POST_HOC outcome

Timeframe: 1 visit roughly 3 hours

Population: 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.

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.

Outcome measures

Measure	Non-Stroke Pilot Group n=12 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Undershoot and Overshoot in Catch Trials Undershoot	37.3 degrees Standard Deviation 2.1	—	—	—
Undershoot and Overshoot in Catch Trials Overshoot	52.4 degrees Standard Deviation 2.6	—	—	—

POST_HOC outcome

Timeframe: 1 visit roughly 3 hours

Population: 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.

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).

Outcome measures

Measure	Non-Stroke Pilot Group n=11 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Movement Settling Time: Reaching Against a Damper-Like Force high damping	1.21 seconds Standard Deviation 0.040	—	—	—
Movement Settling Time: Reaching Against a Damper-Like Force low damping	1.17 seconds Standard Deviation 0.056	—	—	—

POST_HOC outcome

Timeframe: 1 visit roughly 3 hours

Population: 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.

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)

Outcome measures

Measure	Non-Stroke Pilot Group n=11 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Movement Settling Time With Damping Level Cued Visually High Damping Cued Visually	1.16 seconds Standard Deviation 0.041	—	—	—
Movement Settling Time With Damping Level Cued Visually Low Damping Cued Visually	1.13 seconds Standard Deviation 0.030	—	—	—

POST_HOC outcome

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

Population: 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.

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.

Outcome measures

Measure	Non-Stroke Pilot Group n=21 Participants 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.	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.	Robotic Training Group Robotic therapy Subjects with Stroke who will perform the targeted training task: exercise using novel tasks on a robotic recumbent cycle.	Aerobic Training Group Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.
Number of Participants Who Completed the Half-Reversed Cycling Task	21 Participants	—	—	—

Adverse Events

Non-Stroke Pilot Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Adamczyk

University of Wisconsin, Madison

Phone: (608) 263-3231

Email: peter.adamczyk@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place