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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014