Effect of U-Health Service in Stroke Patients

Stroke Clinical Trial

Official title:

U-Health Service Using Mobile Device for Improvement of Post-Stroke Upper Limb Function and Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01815905
• Other study ID #: B-1206/160-005
• Status: Completed
• Phase: N/A
• First received: March 11, 2013
• Last updated: March 3, 2014
• Start date: March 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Mobile program for occupational and speech therapy

• Traditional rehabilitation therapy

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Bundang-gu

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	KT Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	EuroQol(EQ-5D)	measurement of health outcome	4weeks	No
Primary	Fugl-Meyer upper extremity scale	upper extremity function test	4weeks	No
Primary	short form K-FAST (Korean version of Frenchay Aphasia Screening)	speech function screening test	4weeks	No
Secondary	Hand grip strength	hand power measurement	4weeks	No
Secondary	K-WAB(Korean version-the Western Aphasia Battery)	speech evaluation	4weeks	No