NCT03463122

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2014

Typical duration 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

August 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

2.2 years

First QC Date

March 5, 2018

Last Update Submit

March 9, 2018

Conditions

Keywords

strokeneglectvirtual realityhead mount displayrehabilitation

Outcome Measures

Primary Outcomes (3)

  • Change in Field of regard-response time

    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

    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

    sum of all quantified head-rotations with field of regard setting

    Baseline, 4 weeks from baseline, 8 weeks from baseline

Secondary Outcomes (5)

  • Field of view-response time

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Field of view-success rate

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Line bisection test

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Star cancellation test

    Baseline, 4 weeks from baseline, 8 weeks from baseline

  • Catherine Bergego Scale

    Baseline, 4 weeks from baseline, 8 weeks from baseline

Study Arms (2)

Training first

OTHER

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 therapyOther: conventional therapy

Waiting first

OTHER

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 therapyOther: conventional therapy

Interventions

field of regard-focused visual exploration therapy in addition to conventional therapy

Also known as: head mount display
Training firstWaiting first

conventional therapy for stroke rehabilitation

Training firstWaiting first

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Rehabilitation Center

Seoul, 01022, South Korea

Location

Related Publications (2)

  • Shin JH, Kim M, Lee JY, Kim MY, Jeon YJ, Kim K. Feasibility of hemispatial neglect rehabilitation with virtual reality-based visual exploration therapy among patients with stroke: randomised controlled trial. Front Neurosci. 2023 Apr 20;17:1142663. doi: 10.3389/fnins.2023.1142663. eCollection 2023.

  • Kim TL, Kim K, Choi C, Lee JY, Shin JH. FOPR test: a virtual reality-based technique to assess field of perception and field of regard in hemispatial neglect. J Neuroeng Rehabil. 2021 Feb 18;18(1):39. doi: 10.1186/s12984-021-00835-1.

MeSH Terms

Conditions

StrokePerceptual Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joon-Ho Shin

    National Rehabilitation Center of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Team manager of Department of Neurorehabilitation

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 13, 2018

Study Start

August 1, 2014

Primary Completion

October 30, 2016

Study Completion

December 31, 2016

Last Updated

March 13, 2018

Record last verified: 2018-03

Locations