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Completed Phase 1 Interventional Results available

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke

ClinicalTrials.gov ID: NCT02360488

Public ClinicalTrials.gov record NCT02360488. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 1:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke An Assessor-blind, Randomized, Non-inferiority Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The current study will test the effectiveness of a novel home-based telehealth system designed to improve motor recovery and patient education after stroke. A total of 124 subjects (the number may be larger depending on the rate of subject dropout) with arm motor deficits 4-36 weeks after a stroke due to ischemia or to intracerebral hemorrhage will be randomized to receive 6 weeks of intensive arm motor therapy (a) in a traditional in-clinic setting or (b) via in-home telerehabilitation (rehabilitation services delivered to the subject's home via an internet-connected computer). The intensity, duration, and frequency of this therapy will be identical across the two groups, with subjects in both treatment arms receiving 36 sessions (18 supervised and 18 unsupervised), 80 minutes each (including a 10 minute break), over 6 weeks. The primary endpoint is within-subject change in the arm motor Fugl-Meyer (FM) score from the Baseline Visit to 30 Day Follow-Up Visit. Arm motor status is the focus here because it is commonly affected by stroke, is of central importance to many human functions, and is strongly linked to disability and well being after stroke.

Study identification

NCT ID
NCT02360488
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
124 participants

Conditions and interventions

Conditions

Interventions

Device · Behavioral

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2015
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Last update posted
Feb 27, 2020

2015 – 2018

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
University of California, Irvine Irvine California 92697
UCSD Stroke Center San Diego California 92103
Brooks Rehabilitation Clinical Research Center Jacksonville Florida 32216
Emory Rehabilitation Hospital Atlanta Georgia 30322
Rehabilitation Institute of Chicago Chicago Illinois 60611
Spaulding Rehabilitation Hospital Charlestown Massachusetts 02129
Kessler Institute for Rehabilitation Saddle Brook New Jersey 07663
Mount Sinai New York New York 10029
Burke Rehabilitation Hospital White Plains New York 10605
MetroHealth Rehabilitation Institute of Ohio Cleveland Ohio 44109
MUSC Center for Rehabilitation Research in Neurological Conditions Charleston South Carolina 29425
Harborview Medical Center Seattle Washington 98104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02360488, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 27, 2020 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02360488 live on ClinicalTrials.gov.

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