Skip to content

Eyegaze Systems for Spinal Cord Injury: A Feasibility Study

A Longitudinal Clinical Feasibility Study to Evaluate the Psychological and Functional Effects of Using the Tobii™ Eyegaze System by Inpatients With Tetraplegia

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01943656
Enrollment
12
Registered
2013-09-17
Start date
2013-08-31
Completion date
2014-02-28
Last updated
2013-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury

Brief summary

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

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.

Interventions

DEVICETobii™ 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.

Sponsors

Buckinghamshire Healthcare NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire8 weeksChange in score between 0 and 8 weeks.

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale (HADS)8 weeksChange in score between 0 and 8 weeks.

Other

MeasureTime frameDescription
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire8 weeksChange in score between 0 and 8 weeks.

Countries

United Kingdom

Contacts

Primary ContactJoost J. van Middendorp, MD, PhD
Joost.vanMiddendorp@buckshealthcare.nhs.uk+44 1296316783

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026