NCT03300258

Robotic Pedaling Therapy for Targeted Neural Plasticity

Terminated NA Results posted Last updated 5 October 2023

What this trial tests

NA trial testing Robotic therapy in Stroke in 44 participants. Terminated before completion.

Timeline

1 June 2019

Primary endpoint
29 June 2022

29 June 2022

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	44
Start date	1 June 2019
Primary completion	29 June 2022
Estimated completion	29 June 2022
Sites	1 location across United States

Drugs / interventions tested

• Robotic therapy
• Aerobic therapy

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 85, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reaction Time in "Medium" Catch Trials Secondary · 1 visit roughly 3 hours

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

Train High, Catch Medium

Group	Value	95% CI
Group 1	0.366	± 0.038

Train Low, Catch Medium

Group	Value	95% CI
Group 1	0.375	± 0.037

Movement Settling Time: Reaching Against a Spring-Like Torque Secondary · 1 visit roughly 3 hours

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.

"high" stiffness training

Group	Value	95% CI
Group 1	1.21	± 0.068

"low" stiffness training

Group	Value	95% CI
Group 1	1.24	± 0.071

"catch medium" trials when training was "high"

Group	Value	95% CI
Group 1	1.29	± 0.079

"catch medium" trials when training was "low"

Group	Value	95% CI
Group 1	1.40	± 0.096

Undershoot and Overshoot in Catch Trials Secondary · 1 visit roughly 3 hours

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 d

Undershoot

Group	Value	95% CI
Group 1	37.3	± 2.1

Overshoot

Group	Value	95% CI
Group 1	52.4	± 2.6

Movement Settling Time: Reaching Against a Damper-Like Force Secondary · 1 visit roughly 3 hours

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).

high damping

Group	Value	95% CI
Group 2	1.21	± 0.040

low damping

Group	Value	95% CI
Group 2	1.17	± 0.056

Movement Settling Time With Damping Level Cued Visually Secondary · 1 visit roughly 3 hours

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)

High Damping Cued Visually

Group	Value	95% CI
Group 2	1.16	± 0.041

Low Damping Cued Visually

Group	Value	95% CI
Group 2	1.13	± 0.030

Number of Participants Who Completed the Half-Reversed Cycling Task Secondary · 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

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.

Group	Value	95% CI
Group 3	21

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.