Clinical trial NCT05625438: Telerehabilitation Early After Stroke
Official title: Bedside Telerehabilitation Early After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Stroke
Lead sponsor: TRCare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Providence St. Jude Medical Center
First posted: 2022-11-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This clinical trial is designed to address 3 specific aims:

Aim 1: To measure the safety of daily bedside telerehabilitation.

Aim 2: To measure the feasibility of daily bedside telerehabilitation.

Aim 3: To derive a preliminary estimate of motor and functional outcomes in patients engaged in daily bedside telerehabilitation.

Telerehabilitation therapy is delivered over the course of the inpatient rehabilitation stay. A therapist-facing web portal is used for treatment planning and patient monitoring. The treatment approach was initially designed based on an upper-extremity task-specific training manual and Accelerated Skill Acquisition Program.

Each daily 45-minute treatment session is created by a licensed OT or PT and includes:

A. At least 15 min/day of upper extremity exercises. In addition, therapists have the option to incorporate standard exercise equipment (e.g., Theraband or dowels) that can be incorporated into assigned exercises.

B. At least 15 min/day of functional training through games. The study provides 2 controllers with 5 different input devices that are available to drive game play. Games stress various motor control features (e.g., varying movement speed, range of motion, target size, extent of visuomotor tracking, or level of cognitive demand), which are selected and adjusted by the therapist.

C. Five minutes/day of stroke education. The education content targets five categories (Stroke Risk Factors, Stroke Prevention, Effects of Stroke, Diet, and Exercise) and corresponds to the Stroke Knowledge Exam.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. 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.
3. 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.
4. Possess enough arm movement to participate in therapy
5. Informed consent signed by the subject
6. Able to follow simple instructions
7. Study participation is not likely to be significantly limited by agitated behavior

Exclusion Criteria:

1. A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia
2. Expectation that patient's cognitive status will likely interfere substantially with playing assigned games or exercises
3. Deficits in communication that interfere with reasonable study participation
4. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
5. Subject does not speak sufficient English to comply with study procedures
6. Shoulder pain that in the judgement of the study team is likely to substantially limit the amount of telerehabilitation therapy completed

Primary outcomes:
measure: 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
timeFrame: "For approximately 2 weeks, up until 2 days prior to discharge"
Secondary outcomes:
measure: Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage
timeFrame: "baseline" and "immediately after end of treatment"
measure: Box and Blocks Test
timeFrame: "baseline" and "immediately after end of treatment"
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence St. Jude Medical Center
state: California
Study officials:
affiliation: Providence St. Jude Medical Center
name: Natalia Covarrubias-Eckardt, MD
role: PRINCIPAL_INVESTIGATOR
References: