Recruiting

Telerehabilitation

Sponsor:

TRCare, Inc.

Code:

NCT05625438

Conditions

Cerebral Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HandyMotion Treatment Program

Study Details

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.

Conditions

Cerebral Stroke

Study ID

NCT05625438

Start date

Dec 19, 2022

Status verified date

Dec, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bedside Telerehabilitation

Participants will be assigned 45-minute therapy training exercises each day for 5 days per week.

Participants will use the HandyMotion device to interact with the telerehabilitation program displayed on the TV set in the patient room.

Interventions

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 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 [ Time Frame: "For approximately 2 weeks, up until 2 days prior to discharge" ]

Central Contacts and Locations

Central contacts

Locations

Providence St. Jude Medical Center

Recruiting

Fullerton, California, United States, 92835

Contacts

Principal Investigator:

Natalia Covarrubias-Eckardt, MD

More Information

Sponsor

TRCare, Inc.

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by TRCare, Inc. on 2024-12-06.