NCT02013999

Brief Summary

Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2014

Completed
Last Updated

January 30, 2018

Status Verified

January 1, 2018

Enrollment Period

1.1 years

First QC Date

December 3, 2013

Last Update Submit

January 28, 2018

Conditions

Upper Extremity Dysfunction After the Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer upper extremity scale

    for motor evaluation

    baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks

Secondary Outcomes (6)

  • brunnström stage

    baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks

  • Modified Barthel Index

    baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks

  • Medical Research Council (MRC) Scale for Muscle Strength

    baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks

  • Euroqol(EQ)-5D

    baseline(just before beginning the treatment), at the end of the treatment for 2 weeks, 1 month later of the end of the treatment for 2 weeks

  • Virtual reality kinematic data

    everytime when the patient uses program (automatically all recorded)

  • +1 more secondary outcomes

Study Arms (2)

Virtual reality program

EXPERIMENTAL

mobile device for virtual reality program

Other: Virtual reality program for upper extremity rehabilitation

Control

ACTIVE COMPARATOR

standard occupuational therapy

Other: standard occupational therapy

Interventions

Virtual reality program for upper extremity rehabilitationOTHER
Virtual reality program
standard occupational therapyOTHER
Control

Eligibility Criteria

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

You may qualify if:

  • ischemic or hemorrhagic stroke confirmed by brain imaging study
  • upper extremity dysfunction
  • possible to use a simple device

You may not qualify if:

  • delirium, confusion or other evidence related to the consciousness
  • uncontrolled medical or surgical disease
  • unable to command to the order due to severe cognitive impairment
  • visual impairment
  • unable to sit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Study Officials

  • Nam-Jong Paik, Ph.D

    Seoul National University Bundang Hospital, Seongnam, South Korea

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 17, 2013

Study Start

October 1, 2013

Primary Completion

November 24, 2014

Study Completion

November 24, 2014

Last Updated

January 30, 2018

Record last verified: 2018-01

Locations

KR(1)