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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Telerehabilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90067
      • California Rehabilitation Institute
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Moss Rehabilitation Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 years or older
2. Stroke that has been radiologically verified
3. Arm motor FM score <56 (out of 66) at initial visit
4. Box & Block Test score with affected arm is at least 3 blocks in 60 seconds at initial visit
5. Informed consent and behavioral contract signed by the subject
6. Admitted to California Rehabilitation Institute or MossRehab for stroke rehabilitation

Exclusion Criteria:

1. A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
2. A major medical disorder that substantially reduces the likelihood that a subject will be able to comply with all study procedures
3. Severe depression, as defined as Geriatric Depression Scale Score >10 at initial visit
4. Significant cognitive impairment, as defined as Montreal Cognitive Assessment score <22 (lower score permitted if due to aphasia with approval from Dr. Cramer)
5. Deficits in communication that interfere with reasonable study participation
6. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye
7. Life expectancy <6 months
8. Pregnant
9. 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
10. Unable to successfully perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
11. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures
12. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Telerehabilitation; Patients will receive 36 treatment sessions over 6 weeks, consisting of 3 sessions/week that are supervised rehab therapy sessions (which begin with a 30-minute videoconference with the licensed OT or PT), alternating with 3 sessions/week of unsupervised rehab therapy sessions whereby the patient follows the instructions on the screen to engage in rehab therapy. Because patients sometimes miss a session, e.g., due to a conflict, we allow up to 8 weeks for patients to complete their 36 rehab therapy sessions.

Device: Telerehabilitation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Fugl-Meyer Arm Motor Score From Baseline to End of Treatment (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).	60 days

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Moss Rehabilitation Research Institute

Publications and helpful links

General Publications

• Hsieh MY, Chuang SY, Lee CK, Luo CM, Cheng CH, Liao MT, Lin PL, Yang TF, Wu CC. Risks and outcomes of critical limb ischemia in hemodialysis patients: a prospective cohort study. Clin Kidney J. 2022 Dec 8;16(3):585-595. doi: 10.1093/ckj/sfac263. eCollection 2023 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2021
• Primary Completion (Actual): June 22, 2022
• Study Completion (Actual): June 22, 2022

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 1, 2020
• First Posted (Actual): December 8, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: telerehabilitation; telehealth; brain plasticity; telerehab
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 20-000994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A deidentified dataset will be shared with appropriate personnel after the main study manuscript is published.
• IPD Sharing Time Frame: Likely starting 1-2 years after study completion, lasting for several years thereafter.
• IPD Sharing Access Criteria: Data will be shared using common data formats with appropriate personnel.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No