Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-03 @ 5:54 PM
Study NCT ID:
NCT03230695
Status:
UNKNOWN
Last Update Posted:
2022-10-28
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke
Sponsor:
University of Sao Paulo General Hospital
Organization:
Study Overview
Official Title:
Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.
Detailed Description:
The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.
The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.
The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?: