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CompletedNCT02013999Updated Jan 30, 2018

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

An interventional study of Virtual reality program for upper extremity rehabilitation and standard occupational therapy in Upper Extremity Dysfunction After the Stroke, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Randomized
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Upper Extremity Dysfunction After the Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 33 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

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Lead sponsor

Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    Virtual reality program

    mobile device for virtual reality program

    Other: Virtual reality program for upper extremity rehabilitation

  • Active comparator
    Control

    standard occupuational therapy

    Other: standard occupational therapy

Interventions

  • OtherVirtual reality program for upper extremity rehabilitation
  • Otherstandard occupational therapy
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What researchers measure

Primary outcomes

  1. Fugl-Meyer upper extremity scale

    for motor evaluation

    Time frame: 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

  1. brunnström stage

    for motor evaluation

    Time frame: 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

  2. Modified Barthel Index

    for ADL independence

    Time frame: 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

  3. Medical Research Council (MRC) Scale for Muscle Strength

    for motor evaluation

    Time frame: 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

  4. Euroqol(EQ)-5D

    EQ-5D

    Time frame: 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

  5. Virtual reality kinematic data

    Automatically recorded

    Time frame: everytime when the patient uses program (automatically all recorded)

  6. questionnaire

    for user satisfaction

    Time frame: at the end of the treatment for 2 weeks

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Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02013999
Lead sponsor
Seoul National University Bundang Hospital
Responsible party
Nam-Jong Paik (Professor, Seoul National University Bundang Hospital) — Principal investigator
First posted
Dec 17, 2013
Start date
Oct 2013
Primary completion
Nov 24, 2014
Completion
Nov 24, 2014
Last update
Jan 30, 2018

Study contacts

Nam-Jong Paik, Ph.D
principal investigator · Seoul National University Bundang Hospital, Seongnam, South Korea
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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