Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-27 @ 4:40 PM
Study NCT ID:
NCT03872466
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2019-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glove Rehabilitation Application for Stroke Patients
Sponsor:
Barron Associates, Inc.
Organization:
Study Overview
Official Title:
Glove Rehabilitation Application for Stroke Patients (GRASP)
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
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:
GRASP
Brief Summary:
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
Detailed Description:
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: