- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815905
Effect of U-Health Service in Stroke Patients
March 3, 2014 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital
U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
Provides mobile programs for occupational and speech therapy to patients with stroke.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bundang-gu
-
Seongnam-si, Bundang-gu, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- stroke confirmed by brain imaging study
- Impairment in upper extremity function or speech
- native speaker of Korean
Exclusion Criteria:
- previous history of aphasia
- psychiatric or psychotic problem
- severe cognitive dysfunction
- severe hearing or visual loss
- cannot sit with devices
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Traditional therapy
Traditional rehabilitation therapy
|
|
|
Experimental: Mobile program
Mobile program for occupational and speech therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer upper extremity scale
Time Frame: 4weeks
|
upper extremity function test
|
4weeks
|
|
short form K-FAST (Korean version of Frenchay Aphasia Screening)
Time Frame: 4weeks
|
speech function screening test
|
4weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand grip strength
Time Frame: 4weeks
|
hand power measurement
|
4weeks
|
|
K-WAB(Korean version-the Western Aphasia Battery)
Time Frame: 4weeks
|
speech evaluation
|
4weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EuroQol(EQ-5D)
Time Frame: 4weeks
|
measurement of health outcome
|
4weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Nam-Jong Paik, PhD, Seoul National University Bundang Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
March 11, 2013
First Submitted That Met QC Criteria
March 18, 2013
First Posted (Estimate)
March 21, 2013
Study Record Updates
Last Update Posted (Estimate)
March 5, 2014
Last Update Submitted That Met QC Criteria
March 3, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-1206/160-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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