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Eyegaze Systems for Spinal Cord Injury: A Feasibility Study

NCT ID: NCT01943656

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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As technologies are advancing quickly in the healthcare setting, new solutions have become available helping disable people to enhance their ability to communicate. One of these advances is the introduction of the 'eye gaze system'. Through processing eye movements, this device allows a person to write, speak, use the Internet and even control systems in the home or office. In the currently proposed study we aim to evaluate the psychological and functional effects of using the Tobii™ Eyegaze System by inpatients with tetraplegia who are unable to use arms and legs and sometimes are not able to talk because of an impaired respiratory function.

Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™ Eyegaze System by inpatients with tetraplegia results in improved disability perception and independence scores. For the current feasibility study 12 participants will be recruited and assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and 'eyeskills' to instruct the computer system. Positive study outcomes will encourage future studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home environment.

Detailed Description

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Volunteering inpatients will be recruited at the National Spinal Injuries Centre. Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months. It is hypothesised that using the Tobii™ Eyegaze System by inpatients with tetraplegia results in improved disability perception and independence scores. For the current feasibility study 12 participants will be recruited and assessed for 'Appraisal of Disability', 'Mood', 'Assistive Technology perception' and 'eyeskills' to instruct the computer system. Positive study outcomes will encourage future studies of the role of the Tobii™ Eyegaze System in both a rehabilitation and home environment.

Conditions

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Spinal Cord Injury

Keywords

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Spinal Cord Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Tobii™ Eyegaze System

Single arm, open label study.

Group Type EXPERIMENTAL

Tobii™ Eyegaze System

Intervention Type DEVICE

Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months.

Interventions

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Tobii™ Eyegaze System

Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months.

Intervention Type DEVICE

Other Intervention Names

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Eyegaze System, Eye-tracking Operation System

Eligibility Criteria

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Inclusion Criteria

* Spinal Cord Injury at C7 level or above
* American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C or D
* Age equal or higher than 16 years old
* Expected to stay least 10 weeks at the National Spinal Injuries Centre

Exclusion Criteria

* History of severe neurological injuries other than Spinal Cord Injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
* Planned discharge within 10 weeks time
* Psychiatric or cognitive conditions that may interfere with the study
* Patients incapable of providing informed consent
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buckinghamshire Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joost J. van Middendorp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stoke Mandeville Spinal Foundation

Locations

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National Spinal Injuries Centre, Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Joost J. van Middendorp, MD, PhD

Role: CONTACT

Phone: +44 1296316783

Email: [email protected]

Facility Contacts

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Joost J. van Middendorp, MD, PhD

Role: primary

Related Links

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http://www.smsf.org.uk/research%20projects.htm

Website directing to project description and updates

Other Identifiers

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13/EE/0049 (UK NRES)

Identifier Type: -

Identifier Source: org_study_id