Stroke Clinical Trial
Official title:
Robotic Pedaling Therapy for Targeted Neural Plasticity
Verified date | October 2023 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 44 |
Est. completion date | June 29, 2022 |
Est. primary completion date | June 29, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Patients: Inclusion criteria: - Subjects will be stroke patients with persistent moderate unilateral lower extremity deficits, age 50-85 years at time of enrollment. - Time since stroke will be greater than 6 months ("chronic" stroke survivors). - Persistent moderate unilateral lower-limb impairment (defined as NIH Stroke Scale - Motor Leg section score of 1-2, to be discussed with the patient verbally during phone screening and assessed by the investigator during the initial enrollment visit). - Fluent in spoken and written English Exclusion criteria: - Allergy to electrode gel, surgical tape and metals. - Subjects under treatment for infectious diseases will be excluded from the study. - Women who are pregnant or planning to become pregnant during the course of the study will be excluded. - Contraindications for MRI - Age over 85 years at time of enrollment. Healthy Controls: Inclusion criteria: - Ages 18-85 years - Non-Stroke Group 1 ("Matched Controls"): 50-85 years old at time of enrollment, to match the population of stroke patients to be studied - Non-Stroke Group 2 ("Pilot Controls"): 18-50 years old at time of enrollment (Pilot subjects to be initially enrolled early in the design phase of the study, and with enrollment ongoing throughout the study to continue development.) - No known neurologic, psychiatric or developmental disability. - Fluent in spoken and written English Exclusion criteria: - Allergy to electrode gel, surgical tape, and metals. - Subjects under treatment for infectious diseases will be excluded from the study. - Women who are pregnant or planning to become pregnant during the course of the study will be excluded. - Contraindications for MRI - Age over 85 years at time of enrollment. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin, Madison | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Center for Advancing Translational Sciences (NCATS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Six Minute Walk Test (6MWT) Distance | A simple series of laps along a 30 m straight path in a level hallway. | Baseline and at 5 weeks | |
Secondary | Change in Brain Activity in and Near Affected Areas, Through Functional MRI (fMRI) | 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. | Baseline and at 5 weeks | |
Secondary | Change in Timed Up-and-Go Test (TUG) | 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. | Baseline and at 5 weeks | |
Secondary | Change in Self-Selected Walking Speed (SSWS) | A simple test of the speed a person chooses to walk over a 5-meter distance | Baseline and at 5 weeks | |
Secondary | Change in Fastest Comfortable Walking Speed (FCWS) | A similar test of the "fastest comfortable speed" a person can use to walk over the 5-meter distance | Baseline and at 5 weeks | |
Secondary | Change in Center of Pressure (COP) Characteristics | 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. | Baseline and at 5 weeks |
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