NCT01815905

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

March 11, 2013

Last Update Submit

March 3, 2014

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer upper extremity scale

    upper extremity function test

    4weeks

  • short form K-FAST (Korean version of Frenchay Aphasia Screening)

    speech function screening test

    4weeks

Secondary Outcomes (2)

  • Hand grip strength

    4weeks

  • K-WAB(Korean version-the Western Aphasia Battery)

    4weeks

Other Outcomes (1)

  • EuroQol(EQ-5D)

    4weeks

Study Arms (2)

Traditional therapy

ACTIVE COMPARATOR

Traditional rehabilitation therapy

Other: Traditional rehabilitation therapy

Mobile program

EXPERIMENTAL

Mobile program for occupational and speech therapy

Other: Mobile program for occupational and speech therapy

Interventions

Mobile program for occupational and speech therapyOTHER
Mobile program
Traditional rehabilitation therapyOTHER
Traditional therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stroke confirmed by brain imaging study
  • Impairment in upper extremity function or speech
  • native speaker of Korean

You may not qualify if:

  • previous history of aphasia
  • psychiatric or psychotic problem
  • severe cognitive dysfunction
  • severe hearing or visual loss
  • cannot sit with devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Bundang-gu, 463-707, South Korea

Location

MeSH Terms

Conditions

Stroke

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Nam-Jong Paik, PhD

    Seoul National University Bundang Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 21, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

KR(1)