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Clinical Trials/NCT03300258
NCT03300258
Terminated
Not Applicable

Robotic Pedaling Therapy for Targeted Neural Plasticity

University of Wisconsin, Madison1 site in 1 country44 target enrollmentJune 1, 2019
ConditionsStroke

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 29, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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