Eyegaze Systems for Spinal Cord Injury: A Feasibility Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tobii™ Eyegaze System Single arm, open label study. |
Device: 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire [8 weeks]
Change in score between 0 and 8 weeks.
Secondary Outcome Measures
- Hospital Anxiety and Depression Scale (HADS) [8 weeks]
Change in score between 0 and 8 weeks.
Other Outcome Measures
- Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire [8 weeks]
Change in score between 0 and 8 weeks.
Eligibility Criteria
Criteria
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:
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History of severe neurological injuries other than Spinal Cord Injury (eg. Multiple Sclerosis, Cerebral Palsy, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Stroke)
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Planned discharge within 10 weeks time
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Psychiatric or cognitive conditions that may interfere with the study
-
Patients incapable of providing informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Spinal Injuries Centre, Stoke Mandeville Hospital | Aylesbury | Buckinghamshire | United Kingdom | HP21 8AL |
Sponsors and Collaborators
- Buckinghamshire Healthcare NHS Trust
Investigators
- Principal Investigator: Joost J. van Middendorp, MD, PhD, Stoke Mandeville Spinal Foundation
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 13/EE/0049 (UK NRES)