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NCT Number: NCT05625438

Telerehabilitation Early After Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

Location status: Recruiting

Location contact

Natalia Covarrubias-Eckardt, MD

CONTACT

[email protected]

714-992-3000 ext. 1600

Natalia Covarrubias-Eckardt, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HandyMotion Treatment Program

Device

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

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

    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.

Secondary outcomes

  1. Feasibility of daily bedside telerehabilitation based on measurement of patient compliance, as determined by reviewing electronic records of device usage

    Time frame: "baseline" and "immediately after end of treatment"

    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.

  2. Box and Blocks Test

    Time frame: "baseline" and "immediately after end of treatment"

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Johnson K Sun

CONTACT

[email protected]

650-300-2168

Sponsors and collaborators

Lead sponsor

TRCare, Inc.

Industry

Collaborators

  • Providence St. Jude Medical Center

Registry information

Official study title

Bedside Telerehabilitation Early After Stroke

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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