NCT06854978 · Kessler Foundation
R3THA Rehabilitation Feasibility and Usability Study
(RETHA)
What this study is about
The purpose of this study is to assess how the Rehabilitation Technologies for Hand and treatment group$1 (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.
View original scientific description
The purpose of this study is to assess how the Rehabilitation Technologies for Hand and Arm (R3THA) device can be used for rehabilitation of people with stroke. the study will evaluate the feasibility of R3THA as outpatient telerehabilitation administered by trained clinicians to individuals with stroke.
Interventions
OTHER
RETHA
The study will enroll up to 10 participants with stroke who will be paired with trained therapists to receive R3THA telerehabilitation. The participants with stroke will participate in 7 training sessions. The training includes hand and arm exercises.
Primary outcome measures
System Usability Survey
Time frame: 5 weeks
System Usability Scale is a well-established standardized metric used to measure usability perception of computer interfaces and products.
Exergame Questionnaire
Time frame: 5 weeks
It is a questionnaire developed to assess qualitative performance of the device
Performance Survey
Time frame: 5 weeks
It is a qualitative questionnaire with interview aimed at gauging the feasibility of integrating R3THA into the daily routines of individual with stroke/end users.
Fugl-Meyer Assessment for Upper Extremity
Time frame: 5 weeks
A standard clinical measure to assess the level of motor impairment in individuals with stroke.
Box and Blocks Test
Time frame: 5 weeks
box and blocks test is standard measure for hand dexterity and hand-eye coordination
Action Research Arm Test
Time frame: 5 weeks
The standard assessment for functional performance in individuals with stroke
Kinematic Assessment
Time frame: 5 weeks
Kinematic assesment to measure range of motion of the hand and arm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- must be between the ages of 20 and 80
- must have enough movement in my arms and hands to actively interact with the video games as determined by study staff
- must have internet access at home.
- must be comfortable performing basic functions on a computer, such as browsing the internet.
- must be able to sit without a loss of balance while performing activities with my arms and hands as determined by study staff.
Exclusion criteria
- Severe muscle spasms or stiffness (spasticity) in the affected upper limb that limits movement, as determined by study staff. 2\) Thinking problems or have difficulty following instructions 3) Unable to interact with an entire computer screen due to spatial neglect 4) Difficulty understanding words spoken to me (Receptive aphasia) 5) Any other disabling nervous system condition (besides stroke) that has caused residual weakness, impaired range of motion, or spasticity 6) Severe arthritis that limits hand and arm movements 7) Not independent in functional activities/mobility prior to stroke
Where
- West Orange, New Jersey
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2025 · Source of record for eligibility and locations