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NCT02360488 · ClinicalTrials.gov registry record · Phase 1
Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke
A Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 1
- Development phase
- 124
- Enrollment target
NCT02360488 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 124 participants.
The verdict
NCT02360488, a Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 124 participants
- Enrollment target
Study Summary
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.
Interventions
- DEVICE Telerehabilitation Therapy
- BEHAVIORAL In-Clinic Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2015-09 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02360488
The ClinicalTrials.gov registry entry for NCT02360488 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Telerehabilitation Therapy is the first listed.
NCT02360488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02360488 about?
NCT02360488 is a clinical study titled "Telerehabilitation in the Home Versus Therapy In-Clinic for Patients With Stroke". 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 d...
What is the current status of trial NCT02360488?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2015-09. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02360488?
The interventions under investigation include: Telerehabilitation Therapy (DEVICE), In-Clinic Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT02360488?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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