Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect

March 9, 2018 updated by: Joon-Ho Shin, National Rehabilitation Center, Seoul, Korea

Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study

Head-mounted display based virtual reality rehabilitation for hemispatial neglect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators examine about the efficacy of field-of-regard-focused visual exploration therapy implemented using a head-mounted display virtual reality system for hemispatial neglect rehabilitation following stroke.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • presence of left hemispatial neglect as demonstrated by a score above the cut-off on the line bisection test or star cancellation test of the Behavioral Inattention Test, or mild-to-moderate neglect-related functional impairment defined by a score of 1-20 points on the Catherine Bergego Scale
  • age 19 to 65 years
  • first-time right hemispheric ischemic or haemorrhagic stroke as evidenced by brain imaging and medical records
  • a score >25 on the Mini-Mental State Examination

Exclusion Criteria:

  • presence of oculomotor palsies or visual defects as assessed via standard neurological examination
  • orthopaedic disorders affecting neck movement
  • inability to maintain a seated position.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Training first
This group completed 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy followed by four weeks of conventional therapy
Device: field of regard-focused visual exploration therapy
field of regard-focused visual exploration therapy in addition to conventional therapy
Other Names:
  • head mount display
Other: conventional therapy
conventional therapy for stroke rehabilitation
Other: Waiting first
This group completed four weeks of conventional therapy followed by 20 sessions of a field of regard-focused visual exploration therapy program using an head mount display (five daily sessions per week over a period of four weeks) in addition to conventional therapy.
Device: field of regard-focused visual exploration therapy
field of regard-focused visual exploration therapy in addition to conventional therapy
Other Names:
  • head mount display
Other: conventional therapy
conventional therapy for stroke rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Field of regard-response time
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
time interval between target onset and response with field of regard setting
Baseline, 4 weeks from baseline, 8 weeks from baseline
Change in Field of regard-success rate
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
percentage of correct responses (clicking the left or right mouse button in response to a blue or red target, respectively) with field of regard setting
Baseline, 4 weeks from baseline, 8 weeks from baseline
Change in Field of regard-head movement
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
sum of all quantified head-rotations with field of regard setting
Baseline, 4 weeks from baseline, 8 weeks from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Field of view-response time
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
time interval between target onset and response with field of view setting
Baseline, 4 weeks from baseline, 8 weeks from baseline
Field of view-success rate
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
percentage of correct responses (clicking the left or right mouse button in response to a blue or red target, respectively) with field of view setting
Baseline, 4 weeks from baseline, 8 weeks from baseline
Line bisection test
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
Participants were asked to bisect the given lines by marking the centre of each line using their preferred or unaffected hand
Baseline, 4 weeks from baseline, 8 weeks from baseline
Star cancellation test
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
The experimenter crossed out the two small, central stars of the sheet as an example, following which participants were asked to mark the remaining small stars.
Baseline, 4 weeks from baseline, 8 weeks from baseline
Catherine Bergego Scale
Time Frame: Baseline, 4 weeks from baseline, 8 weeks from baseline
a standardised checklist designed to detect the degree of neglect during everyday life via direct observation of functioning during ten tasks
Baseline, 4 weeks from baseline, 8 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Rehabilitation Center, Seoul, Korea

Collaborators

Hanyang University

Investigators

  • Principal Investigator: Joon-Ho Shin, National Rehabilitation Center of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

October 30, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRC-2014-04-022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on field of regard-focused visual exploration therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe