Telerehabilitation Early After Stroke
ConditionCerebral Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRCare, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
HandyMotion Treatment Program
DeviceA pair of sensor-based wireless remote controllers to allow the performance of functional exercises and games that target arm movement.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Bedside TelerehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Safety will be measured in terms of adverse events (AEs) deemed related to use of the telerehabilitation system on a probable or definite basis.
Time frame
"For approximately 2 weeks, up until 2 days prior to discharge"Secondary outcomes
1
Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage
Feasibility will be measured in terms of patient compliance, specifically the fraction of days where a patient is assigned to do bedside telerehabilitation and initiates a treatment session. Any factors related to reduced compliance, including technical and medical factors, will be recorded.
Time frame
"baseline" and "immediately after end of treatment"2
Box and Blocks Test
Measure of Upper Extremity Function by assessing unilateral gross manual dexterity. Participant will be asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds.
Time frame
"baseline" and "immediately after end of treatment"Sponsors and contacts
Click on the lead sponsor to view all of their trials.
TRCare, Inc.
Lead sponsor
Providence St. Jude Medical Center
Collaborator
Source ClinicalTrials.gov