Telerehabilitation Early After Stroke

The purpose of this research study is to assess the feasibility of initiating telerehab in early stages after stroke during patient admission to an inpatient rehabilitation facility. Patients will complete 36 sessions of telerehab 6 days/week up to 8 weeks with a telehealth system provided in their hospital room and at their home. The system will include rehabilitation activities/exercises, education, and assessments to evaluate the patient experience and measure patient outcomes at the end of a 6-week course of telerehab.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Rehabilitation Institute, Los Angeles, California, United States

About this study

Stroke is a major cause of disability. Loss of movement is a major part of this. Studies show that high doses of rehabilitation therapy can reduce disability, but many patients do not receive this, e.g., due to obstacles such as difficulty accessing care. The research team has previously found that telerehabilitation is an effective way to deliver care and improve outcomes. These prior studies were performed after hospital discharge, when patients were already back at home. The current study aims to extend this work by introducing telerehabilitation to the bedside of patients admitted to an inpatient rehabilitation facility. In this study, key areas of interest include issues related to, and the clinical effects of, telerehabilitation that is started during the rehab admission and is continued after discharge in the patient's home.

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 has been radiologically verified
Arm motor FM score <56 (out of 66) at initial visit
Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
Informed consent and behavioral contract signed by the subject
Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation

Exclusion criteria

A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit
Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
Deficits in communication that interfere with reasonable study participation
Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
Life expectancy <6 months
Pregnant
Receipt of Botox to arms, legs, or trunk in the preceding 6 months, or expectation that Botox will be administered to the arm, leg, or trunk within 3 months of study enrollment
Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
Expectation that subject will not have a single domicile address during the 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for the telerehab system

Treatment and study plan

Telerehabilitation

Device

The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned remote-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system. During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.

Primary outcomes

Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (60 Days)

Time frame: 60 days

Measure of arm impairment. Scores range from 0-66, with higher numbers reflecting less arm impairment.

We will be measuring change in scores from baseline to end of treatment (60 days).

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

Moss Rehabilitation Research Institute

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Dec 8, 2020
Registry last updated: Apr 19, 2023

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.

Published trials that share one or more normalized conditions with this study.

Completed