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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: Completed Phase 1 study, sponsored by University of California, Irvine.
NCT02360488 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 124 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The full name of this scale is the arm motor Fugl-Meyer scale. it measures arm motor impairment, which is in the body structure/function domain. It consists of 33 individual assessments that are summed to generate a total arm motor Fugl-Meyer score. Scores range from 0-66, which higher values being better (and so 66 being normal). There are no subscores evaluated.
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 |
What the finished NCT02360488 record still lists
NCT02360488 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 2 interventions - of which Telerehabilitation Therapy is the first listed.
NCT02360488 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02360488's enrollment target sits among peer trials
124 471st of 2000 higher than 1,526 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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