The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients

NCT ID: NCT02013999

Last Updated: 2018-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-11-24

Brief Summary

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

Detailed Description

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This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity \[FMA-UE\], Brunnstr¨om stage \[B-stage\] for the arm and the hand, manual muscle testing \[MMT\], modified Barthel index \[MBI\], EuroQol-5 Dimension \[EQ-5D\], and Beck Depression Inventory \[BDI\]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.

Conditions

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Upper Extremity Dysfunction After the Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Virtual reality program

mobile device for virtual reality program

Group Type EXPERIMENTAL

Virtual reality program for upper extremity rehabilitation

Intervention Type OTHER

Control

standard occupuational therapy

Group Type ACTIVE_COMPARATOR

standard occupational therapy

Intervention Type OTHER

Interventions

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Virtual reality program for upper extremity rehabilitation

Intervention Type OTHER

standard occupational therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nam-Jong Paik, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital, Seongnam, South Korea

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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B-1306/208-005

Identifier Type: -

Identifier Source: org_study_id

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