Effect of U-Health Service in Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
KT corporation
Information provided by (Responsible Party):
Nam-Jong Paik, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01815905
First received: March 11, 2013
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Stroke
Other: Mobile program for occupational and speech therapy
Other: Traditional rehabilitation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Fugl-Meyer upper extremity scale [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    upper extremity function test

  • short form K-FAST (Korean version of Frenchay Aphasia Screening) [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    speech function screening test


Secondary Outcome Measures:
  • Hand grip strength [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    hand power measurement

  • K-WAB(Korean version-the Western Aphasia Battery) [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    speech evaluation


Other Outcome Measures:
  • EuroQol(EQ-5D) [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
    measurement of health outcome


Enrollment: 36
Study Start Date: March 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 11, 2013
Last Updated: March 3, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on April 16, 2014