Telerehabilitation Early After Stroke

NCT05625438 | Recruiting FDA Device

• 1 other identifier: TRC-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  "For approximately 2 weeks, up until 2 days prior to discharge"

Secondary Outcomes (2)

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

  "baseline" and "immediately after end of treatment"

• Box and Blocks Test

  "baseline" and "immediately after end of treatment"

Study Arms (1)

Bedside Telerehabilitation

EXPERIMENTAL

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.

Device: HandyMotion Treatment Program

Interventions

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.

Bedside Telerehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TRCare, Inc.: lead
• Providence St. Jude Medical Center: collaborator

Study Sites (1)

Providence St. Jude Medical Center

Fullerton, California, 92835, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Natalia Covarrubias-Eckardt, MD

  Providence St. Jude Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnson K Sun

CONTACT

650-300-2168; kit@trcare.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 23, 2022
• Study Start: December 19, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)