Robotic Pedaling Therapy for Targeted Neural Plasticity
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 1/18/2019 |
| Start Date: | January 1, 2019 |
| End Date: | March 2022 |
| Contact: | Peter G Adamczyk, Ph.D. |
| Email: | peter.adamczyk@wisc.edu |
| Phone: | 608-263-3231 |
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.
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.
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.
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