Head Mount Display-based Virtual Reality Rehabilitation of Hemispatial Neglect

Not Applicable

Completed

• Conditions: Neglect, Hemispatial; Stroke
• Interventions: Device: field of regard-focused visual exploration therapy; Other: conventional therapy

• Registration Number: NCT03463122
• Lead Sponsor: National Rehabilitation Center, Seoul, Korea

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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2016-10-30
• Study Completion: 2016-12-31
• Status Verified: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-09
• Last Update Submitted: 2018-03-09
• Study First Posted: 2018-03-13
• Last Update Posted: 2018-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Training first	field of regard-focused visual exploration therapy	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
Training first	conventional therapy	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
Waiting first	field of regard-focused visual exploration 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.
Waiting first	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.

Primary Outcome Measures

Name	Time	Method
Change in Field of regard-response time	Baseline, 4 weeks from baseline, 8 weeks from baseline	time interval between target onset and response with field of regard setting
Change in Field of regard-success rate	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
Change in Field of regard-head movement	Baseline, 4 weeks from baseline, 8 weeks from baseline	sum of all quantified head-rotations with field of regard setting

Secondary Outcome Measures

Name	Time	Method
Field of view-response time	Baseline, 4 weeks from baseline, 8 weeks from baseline	time interval between target onset and response with field of view setting
Field of view-success rate	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
Line bisection test	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
Star cancellation test	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.
Catherine Bergego Scale	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

Trial Locations

Locations (1)

National Rehabilitation Center; 🇰🇷 Seoul, Korea, Republic of