Back to resultsHead Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect
Primary Purpose
Stroke, Neglect, Hemispatial
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
field of regard-focused visual exploration therapy
conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, neglect, virtual reality, head mount display, rehabilitation
Eligibility Criteria
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.
Sites / Locations
- National Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Training first
Waiting first
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Change in Field of regard-response time
time interval between target onset and response with field of regard setting
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
Change in Field of regard-head movement
sum of all quantified head-rotations with field of regard setting
Secondary Outcome Measures
Field of view-response time
time interval between target onset and response with field of view setting
Field of view-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 view setting
Line bisection test
Participants were asked to bisect the given lines by marking the centre of each line using their preferred or unaffected hand
Star cancellation test
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.
Catherine Bergego Scale
a standardised checklist designed to detect the degree of neglect during everyday life via direct observation of functioning during ten tasks
Full Information
NCT ID
NCT03463122
First Posted
March 5, 2018
Last Updated
March 9, 2018
Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Hanyang University
1. Study Identification
Unique Protocol Identification Number
NCT03463122
Brief Title
Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect
Official Title
Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
October 30, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Rehabilitation Center, Seoul, Korea
Collaborators
Hanyang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Head-mounted display based virtual reality rehabilitation for hemispatial neglect.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Neglect, Hemispatial
Keywords
stroke, neglect, virtual reality, head mount display, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training first
Arm Type
Other
Arm Description
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
Arm Title
Waiting first
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
field of regard-focused visual exploration therapy
Other Intervention Name(s)
head mount display
Intervention Description
field of regard-focused visual exploration therapy in addition to conventional therapy
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
conventional therapy for stroke rehabilitation
Primary Outcome Measure Information:
Title
Change in Field of regard-response time
Description
time interval between target onset and response with field of regard setting
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Change in Field of regard-success rate
Description
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
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Change in Field of regard-head movement
Description
sum of all quantified head-rotations with field of regard setting
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary Outcome Measure Information:
Title
Field of view-response time
Description
time interval between target onset and response with field of view setting
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Field of view-success rate
Description
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
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Line bisection test
Description
Participants were asked to bisect the given lines by marking the centre of each line using their preferred or unaffected hand
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Star cancellation test
Description
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.
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
Title
Catherine Bergego Scale
Description
a standardised checklist designed to detect the degree of neglect during everyday life via direct observation of functioning during ten tasks
Time Frame
Baseline, 4 weeks from baseline, 8 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon-Ho Shin
Organizational Affiliation
National Rehabilitation Center of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Rehabilitation Center
City
Seoul
ZIP/Postal Code
01022
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
33602254
Citation
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.
Results Reference
derived
Learn more about this trial
Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect
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