Robotic Pedaling Therapy for Targeted Neural Plasticity

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Non-Stroke Comparison Group	Robotic therapy	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.
Non-Stroke Pilot Group	Robotic therapy	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.
Non-Stroke Pilot Group	Aerobic therapy	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.
Robotic Training Group	Robotic therapy	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	Aerobic therapy. Subjects with Stroke who will perform aerobic pedaling, duration-matched to the Robotic group.

Primary Outcome Measures

Name	Time	Method
Change in Six Minute Walk Test (6MWT) Distance	Baseline and at 5 weeks	A simple series of laps along a 30 m straight path in a level hallway.

Secondary Outcome Measures

Name	Time	Method
Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)	Baseline and at 5 weeks	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.
Change in Self-Selected Walking Speed (SSWS)	Baseline and at 5 weeks	A simple test of the speed a person chooses to walk over a 5-meter distance
Change in Timed Up-and-Go Test (TUG)	Baseline and at 5 weeks	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.
Change in Fastest Comfortable Walking Speed (FCWS)	Baseline and at 5 weeks	A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance
Change in Center of Pressure (COP) Characteristics	Baseline and at 5 weeks	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.