Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-07 @ 6:57 AM
Study NCT ID:
NCT03300258
Status:
TERMINATED
Last Update Posted:
2023-10-05
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Robotic Pedaling Therapy for Targeted Neural Plasticity
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Robotic Pedaling Therapy for Targeted Neural Plasticity
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Original study plan required re-evaluation and the decision was made to pivot to developing tests and exercises on healthy population
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4UL1TR000427-10 | NIH | None | https://reporter.nih.gov/quic… | View |
| A196200 | OTHER | UW Madison | View | |
| ENGR\MECHANICAL ENGR | OTHER | UW Madison | View | |
| Protocol Version 1.8, 3/2017 | OTHER | UW Madison | View |