ACTIVE_NOT_RECRUITING

Telerehabilitation Early After CNS Injury

Conditions

Cerebral Stroke Traumatic Brain Injury Spinal Cord Injuries Stroke Traumatic Brain Injuries Telerehabilitation Brain Plasticity Telehealth

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, traumatic brain injury (TBI) and/or spinal cord injury (SCI). 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.

Official Title

Bedside Telerehabilitation Early After CNS Injury

Quick Facts

Study Start:2024-05-09

Study Completion:2025-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06069999

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 years or older 2. CNS injury with onset in the prior 90 days 1. For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage. 2. For traumatic brain injury: History that is consistent with TBI; and score on the Revised Rancho Levels of Cognitive Functioning Scale is at least 6 out of 10. 3. For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI. 3. At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box \& Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds. 4. Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed. 5. Informed consent signed by the subject (no surrogate consent permitted for this study) 6. Able to follow simple instructions 7. Study participation is not likely to be significantly limited by agitated behavior	1. A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis 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 TR therapy completed

Inclusion Criteria

Exclusion Criteria

1. Age 18 years or older
2. CNS injury with onset in the prior 90 days
1. For stroke: Stroke that is radiologically verified and due to ischemia or to intracerebral hemorrhage.
2. For traumatic brain injury: History that is consistent with TBI; and score on the Revised Rancho Levels of Cognitive Functioning Scale is at least 6 out of 10.
3. For spinal cord injury: Traumatic or nontraumatic, incomplete cervical SCI.
3. At least one arm must have motor deficits that are neither very mild nor devastating (dense arm plegia). Operationally, this requires that the Visit 1 Box \& Block Test score is at least 1 block, but no more than 30 blocks, in 60 seconds.
4. Possess enough arm movement to participate in therapy, including able to hold the HandyMotion device in the paretic hand(s), using an assistive device if needed.
5. Informed consent signed by the subject (no surrogate consent permitted for this study)
6. Able to follow simple instructions
7. Study participation is not likely to be significantly limited by agitated behavior

1. A major, active, coexistent neurological or psychiatric disease that would limit study participation, e.g., advanced dementia or active psychosis
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 TR therapy completed

Contacts and Locations

Principal Investigator

Michael Su, MD

PRINCIPAL_INVESTIGATOR

California Rehabilitation Institute

Study Locations (Sites)

California Rehabilitation Institute

Los Angeles, California, 90095

United States

Casa Colina Hospital and Centers for Healthcare

Pomona, California, 91769

United States

Brooks Rehabilitation

Jacksonville, Florida, 32216

United States

Jefferson Moss-Magee Rehabilitation

Philadelphia, Pennsylvania, 19102

United States

University of Utah - Craig H. Neilsen Rehabilitation Hospital

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: TRCare, Inc.

Michael Su, MD, PRINCIPAL_INVESTIGATOR, California Rehabilitation Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-09

Study Completion Date2025-10-30

Study Record Updates

Study Start Date2024-05-09

Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

Stroke
Traumatic Brain Injuries
Spinal Cord Injuries
Telerehabilitation
Brain Plasticity
Telehealth

Additional Relevant MeSH Terms

Cerebral Stroke
Traumatic Brain Injury
Spinal Cord Injuries