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Effect of U-Health Service in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobile program for occupational and speech therapy
Traditional rehabilitation therapy
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional therapy

Mobile program

Arm Description

Traditional rehabilitation therapy

Mobile program for occupational and speech therapy

Outcomes

Primary Outcome Measures

Fugl-Meyer upper extremity scale
upper extremity function test
short form K-FAST (Korean version of Frenchay Aphasia Screening)
speech function screening test

Secondary Outcome Measures

Hand grip strength
hand power measurement
K-WAB(Korean version-the Western Aphasia Battery)
speech evaluation

Full Information

First Posted
March 11, 2013
Last Updated
March 3, 2014
Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01815905
Brief Title
Effect of U-Health Service in Stroke Patients
Official Title
U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
KT Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Provides mobile programs for occupational and speech therapy to patients with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional therapy
Arm Type
Active Comparator
Arm Description
Traditional rehabilitation therapy
Arm Title
Mobile program
Arm Type
Experimental
Arm Description
Mobile program for occupational and speech therapy
Intervention Type
Other
Intervention Name(s)
Mobile program for occupational and speech therapy
Intervention Type
Other
Intervention Name(s)
Traditional rehabilitation therapy
Primary Outcome Measure Information:
Title
Fugl-Meyer upper extremity scale
Description
upper extremity function test
Time Frame
4weeks
Title
short form K-FAST (Korean version of Frenchay Aphasia Screening)
Description
speech function screening test
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
hand power measurement
Time Frame
4weeks
Title
K-WAB(Korean version-the Western Aphasia Battery)
Description
speech evaluation
Time Frame
4weeks
Other Pre-specified Outcome Measures:
Title
EuroQol(EQ-5D)
Description
measurement of health outcome
Time Frame
4weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Bundang-gu
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of U-Health Service in Stroke Patients

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