Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect

Stroke Clinical Trial

Official title:

Virtual Reality Based Visual Perception Evaluation and Rehabilitation-pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463122
• Other study ID #: NRC-2014-04-022
• Status: Completed
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 9, 2018
• Start date: August 1, 2014
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2018
• Source: National Rehabilitation Center, Seoul, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 31, 2016
• Est. primary completion date: October 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neglect, Hemispatial
• Perceptual Disorders
• Stroke

Intervention

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

Other:
• conventional therapy
conventional therapy for stroke rehabilitation

Locations

Country	Name	City	State
Korea, Republic of	National Rehabilitation Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
National Rehabilitation Center, Seoul, Korea	Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Field of view-response time	time interval between target onset and response with field of view setting	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	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	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	Line bisection test	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
Secondary	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.	Baseline, 4 weeks from baseline, 8 weeks from baseline
Secondary	Catherine Bergego Scale	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