NCT05625438 · TRCare, Inc.
Telerehabilitation Early After Stroke
What this study is about
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke. The therapy treatment targets to improve treatment group$1 function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period.
View original scientific description
The goal of this clinical trial is to assess the safety and feasibility of providing extra doses of rehabilitation therapy for persons with a recent stroke. The therapy treatment targets to improve arm function by introducing telerehabilitation to the bedside of participants during the inpatient rehab admission period. Participants will use a newly developed functional training system (HandyMotion) to access therapy treatment program directly from their hospital room. HandyMotion is a sensor-based training system that can connect to the TV set in the hospital room, enabling patients to access their therapy training program to practice rehab-oriented games and exercises ad libitum, at any time of the day.
Interventions
DEVICE
HandyMotion Treatment Program
A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
Primary outcome measures
Safety of daily beside telerehabilitation based on incidence of treatment-emergent adverse events as assessed by regular review of the medical record and patient interview
Time frame: "For approximately 2 weeks, up until 2 days prior to discharge"
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
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
- Age 18 years or older
- Stroke that is radiologically verified, due to ischemia or to intracerebral hemorrhage, and with time of stroke onset \<30 days prior to enrollment; or traumatic brain injury.
- Unilateral arm motor deficits that are neither trivial (no arm weakness) or devastating (arm plegia). This requires that the baseline Box \& Block Test score with affected arm to be at least 1 block in 60 seconds but no more than 90% of the number of blocks with the good arm.
- Possess enough arm movement to participate in therapy
- Informed consent signed by the subject
- Able to follow simple instructions
- Study participation is not likely to be significantly limited by agitated behavior
Exclusion criteria
- A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia
- Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
- Deficits in communication that interfere with reasonable study participation
- Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
- Subject does not speak sufficient English to comply with study procedures
- Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of telerehabilitation therapy completed
Where
- Fullerton, California
Collaborators
Providence St. Jude Medical Center
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 Dec 6, 2024 · Source of record for eligibility and locations