Safety and Efficacy of NeuroTechR3 System for Upper Extremity Recovery After Stroke

NCT07769281 | Recruiting FDA Device

• 1 other identifier: 00090019
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This research aims to understand the feasibility and effectiveness of using the NeuroTechR3 System to improve upper extremity function after stroke.

Conditions

Stroke

Keywords

stroke; upper extremity rehab

Outcome Measures

Primary Outcomes (2)

• Upper Extremity Strength and Function

  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

  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 Outcomes (1)

• Care Transition

  Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.

Study Arms (1)

NeuroTechR3 System

EXPERIMENTAL

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.

Device: NeuroTechR3 Computer Rehabilitation System

Interventions

NeuroTechR3 Computer Rehabilitation System DEVICE

Participants will complete three sessions a week, each lasting for 30 minutes. The sessions consist of upper extremity rehabilitation games on the computer.

NeuroTechR3 System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooks Rehabilitation: lead
• NeuroTechR3: collaborator

Study Sites (1)

Brooks Rehabilitation Hospital - Bartram Campus

Jacksonville, Florida, 32258, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Hannah Grimes

CONTACT

904-528-3159; hannah.grimes@brooksrehab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Clinical Integration and Research

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)