Safety and Efficacy of NeuroTechR3 System for Upper Extremity Recovery After Stroke
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrooks Rehabilitation
About this trial
This research aims to understand the feasibility and effectiveness of using the NeuroTechR3 System to improve upper extremity function after stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
NeuroTechR3 Computer Rehabilitation System
DeviceParticipants will complete three sessions a week, each lasting for 30 minutes. The sessions consist of upper extremity rehabilitation games on the computer.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: NeuroTechR3 SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.2
Questionnaires
The System Usability Scale measures the perceived usability, ease of use, and learnability of the system. An increase in score indicates better usability.
Time frame
Mid-intervention within 3 days of discharging from the inpatient rehabilitation facility and post-intervention at 6 weeks.Secondary outcomes
1
Care Transition
The NeuroTechR3 System evaluates range of motion, speed, and accuracy for the hand and arm. An increase in kinematic data indicates improved functioning.
Time frame
Pre-intervention, mid-intervention within 3 days of discharging from the inpatient rehabilitation facility, and post-intervention at 6 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brooks Rehabilitation
Lead sponsor
NeuroTechR3
Collaborator
Source ClinicalTrials.gov