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Effect of U-Health Service in Stroke Patients

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ClinicalTrials.gov Identifier: NCT01815905
Recruitment Status : Completed
First Posted : March 21, 2013
Last Update Posted : March 5, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Stroke Other: Mobile program for occupational and speech therapy Other: Traditional rehabilitation therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia
Study Start Date : March 2013
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Traditional therapy
Traditional rehabilitation therapy
Other: Traditional rehabilitation therapy
Experimental: Mobile program
Mobile program for occupational and speech therapy
Other: Mobile program for occupational and speech therapy


Outcome Measures

Primary Outcome Measures :
  1. Fugl-Meyer upper extremity scale [ Time Frame: 4weeks ]
    upper extremity function test

  2. short form K-FAST (Korean version of Frenchay Aphasia Screening) [ Time Frame: 4weeks ]
    speech function screening test


Secondary Outcome Measures :
  1. Hand grip strength [ Time Frame: 4weeks ]
    hand power measurement

  2. K-WAB(Korean version-the Western Aphasia Battery) [ Time Frame: 4weeks ]
    speech evaluation


Other Outcome Measures:
  1. EuroQol(EQ-5D) [ Time Frame: 4weeks ]
    measurement of health outcome


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815905


Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
KT Corporation
Investigators
Study Chair: Nam-Jong Paik, PhD Seoul National University Bundang Hospital
More Information

Responsible Party: Nam-Jong Paik, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01815905     History of Changes
Other Study ID Numbers: B-1206/160-005
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases