- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07769281
Safety and Efficacy of NeuroTechR3 System for Upper Extremity Recovery After Stroke (R3)
August 12, 2026 updated by: mark.bowden, Brooks Rehabilitation
This research aims to understand the feasibility and effectiveness of using the NeuroTechR3 System to improve upper extremity function after stroke.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hannah Grimes
- Phone Number: 904-528-3159
- Email: hannah.grimes@brooksrehab.org
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32258
- Recruiting
- Brooks Rehabilitation Hospital - Bartram Campus
-
Contact:
- Hannah Grimes
- Phone Number: 904-528-3159
- Email: hannah.grimes@brooksrehab.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥18 years at the time of enrollment
- Diagnosed with stroke
- No other peripheral or central neurological condition limiting target upper extremity function (previous stroke is ok)
- Indicated for upper extremity training procedures by participant's treating physician, occupational therapist, or physical therapist
- Capable of providing informed consent
- Participant demonstrates active extension of wrist and activation of at least two other digits plus thumb activation
Exclusion Criteria:
- In the opinion of the investigators, the study is not safe or appropriate for the participant, and/or the participant is unlikely to return for the follow-up visits per the protocol to return the device at 4 weeks post discharge
- Visual impairment that would severely limit ability to see a computer screen for participation in sessions, including severe spatial neglect making the person unable to interact with an entire computer screen
- Inability to follow a 3-step motor command
- Severe upper extremity tone that will limit participation in study
- No internet access at home
- Severe receptive aphasia
- Severe arthritis that limits hand and arm movements
- Not independent in functional activities/mobility prior to stroke
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NeuroTechR3 System
Participants will be engaging in six weeks of intervention sessions using the NeuroTechR3 System while in the Brooks Rehabilitation Hospital under the direct supervision of a study staff member.
Participants will then take the NeuroTechR3 System and a laptop home to complete intervention sessions in their home after discharge without the supervision of study staff.
Each session is 30 minutes and 3 times a week.
|
Participants will complete three sessions a week, each lasting for 30 minutes.
The sessions consist of upper extremity rehabilitation games on the computer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Strength and Function
Time Frame: Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.
|
The Fugle-Meyer test is a simple, standardized test used to assess a person's exercise capacity and functional mobility.
An increase in score reflects an improvement in mobility and upper extremity function.
|
Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.
|
|
Questionnaires
Time Frame: Mid-intervention within 3 days of discharging from the inpatient rehabilitation facility and post-intervention at 6 weeks.
|
The System Usability Scale measures the perceived usability, ease of use, and learnability of the system.
An increase in score indicates better usability.
|
Mid-intervention within 3 days of discharging from the inpatient rehabilitation facility and post-intervention at 6 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Care Transition
Time Frame: Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.
|
The NeuroTechR3 System evaluates range of motion, speed, and accuracy for the hand and arm.
An increase in kinematic data indicates improved functioning.
|
Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
August 12, 2026
First Submitted That Met QC Criteria
August 12, 2026
First Posted (Actual)
August 17, 2026
Study Record Updates
Last Update Posted (Actual)
August 17, 2026
Last Update Submitted That Met QC Criteria
August 12, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00090019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.