Status:
TERMINATED
Robotic Pedaling Therapy for Targeted Neural Plasticity
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
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 me...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2022
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03300258
Start Date
June 1 2019
End Date
June 29 2022
Last Update
October 5 2023
Active Locations (1)
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1
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53706