Robotic Pedaling Therapy for Targeted Neural Plasticity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Wisconsin, Madison
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change in Six Minute Walk Test (6MWT) Distance
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Six Minute Walk Test (6MWT) Distance
Time Frame: Baseline and at 5 weeks
A simple series of laps along a 30 m straight path in a level hallway.
Secondary Outcomes
- Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI)(Baseline and at 5 weeks)
- Change in Self-Selected Walking Speed (SSWS)(Baseline and at 5 weeks)
- Change in Fastest Comfortable Walking Speed (FCWS)(Baseline and at 5 weeks)
- Change in Timed Up-and-Go Test (TUG)(Baseline and at 5 weeks)
- Change in Center of Pressure (COP) Characteristics(Baseline and at 5 weeks)