Clinical trial NCT01943656: Eyegaze Systems for Spinal Cord Injury: A Feasibility Study
Official title: A Longitudinal Clinical Feasibility Study to Evaluate the Psychological and Functional Effects of Using the Tobii™ Eyegaze System by Inpatients With Tetraplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Lead sponsor: Buckinghamshire Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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:

* 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

Primary outcomes:
measure: Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 8 weeks
Other outcomes:
measure: Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
timeFrame: 8 weeks
Locations:
city: Aylesbury
country: United Kingdom
facility: National Spinal Injuries Centre, Stoke Mandeville Hospital
state: Buckinghamshire
Study officials:
affiliation: Stoke Mandeville Spinal Foundation
name: Joost J. van Middendorp, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: