NCT02258789

Brief Summary

There is a lack of effective rehabilitation methods for visio-spatial neglect (VSN). By using virtual technology, a new method (virtual reality, VR method) has been created which focuses on stimulating attention networks: top down scanning training in a 3D game, combined with intense visual, audio and tactile bottom-up stimulation, also including visuo-motor training. Objective. To evaluate clinical and functional improvement in stroke patients with VSN, as well as before and after training with the new VR method Method:- An intense visio spatial scanning training, enhanced by directed visual, audio and tactile stimulation cues and feedback, also including visio-motor activation was designed in a VR game. The in-house developed software was based on the Tetris game. The VR method consists of an interactive 3D environment: a desktop computer, a monitor, 3D glasses and a force feedback interface. 15 patients with chronic (\>6 months) visio spatial neglect was included due to right-sided ischemia. A VR neglect test battery including a Posner task were repeated three times during a 5 weeks baseline before the training started (to establish the chronic state) and again after 15 hours training (3x1 h for 5 weeks). Evaluation of a new method for training attention after stroke causing visio spatial neglect. The method has been designed for home rehabilitation and is well suited for a tele-medicine approach. It was built with standard components and is easy to manufacture at a low cost. The idea is to give access to effective training, to make it available at the stroke unit with the possibility for the patient to loan it it at discharge for home rehabilitation. The concept of an all in one, easy-to-use device for testing, training and outcome evaluation should be beneficial These preliminare results has been promising and indicates that the RehAtt™ method could become an further developed into an effective and stimulating intervention tool that would lower rehabilitation costs and reduce tiresome travelling to hospitals for training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

1.8 years

First QC Date

June 9, 2014

Last Update Submit

October 2, 2014

Conditions

Keywords

Stroke, rehabilitation, spatial neglect

Outcome Measures

Primary Outcomes (1)

  • Neglect assessment clinical and behavioural

    Change in score in; Star cancellation test, Line Bisection, Baking tray task, Posner task, Extinction, Catherine Bergego scale (CBS)

    within 1 week after intervention

Secondary Outcomes (1)

  • Catherine Bergego scale

    6 month follow up

Study Arms (1)

intervention - control

EXPERIMENTAL

15 hours ( 3 times a week in 5 weeks) intense visio spatial scanning training Virtual Reality-method

Other: VR-method

Interventions

Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality

Also known as: RehAtt
intervention - control

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neglect \> 6 months and after regular rehabilitation Stroke due to right sided ischemic infarcts

You may not qualify if:

  • Severe visual impairment, severe medical illness, severe depression or cognitive dysfunction (MMSE ≤ 23 points).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Neuroscience

Umeå, Umea, 903 21, Sweden

Location

MeSH Terms

Conditions

Perceptual DisordersStroke

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Helena Fordell, MD,

    Department of Pharmacology and Clinical Neuroscience Umea University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

October 7, 2014

Study Start

September 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations