RecruitingNot ApplicableNCT05625438

Telerehabilitation Early After Stroke

Bedside Telerehabilitation Early After Stroke


Sponsor

TRCare, Inc.

Enrollment

20 participants

Start Date

Dec 19, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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

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Interventions

DEVICEHandyMotion Treatment Program

A pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.


Locations(1)

Providence St. Jude Medical Center

Fullerton, California, United States

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NCT05625438


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