Eyegaze Systems for Spinal Cord Injury: A Feasibility Study

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01943656
• Other study ID #: 13/EE/0049 (UK NRES)
• Status: Not yet recruiting
• Phase: Phase 4
• First received: July 22, 2013
• Last updated: September 12, 2013
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: Buckinghamshire Healthcare NHS Trust
• Contact: Joost J. van Middendorp, MD, PhD
• Phone: +44 1296316783
• Email: Joost.vanMiddendorp[@]buckshealthcare.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	National Spinal Injuries Centre, Stoke Mandeville Hospital	Aylesbury	Buckinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Buckinghamshire Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire	Change in score between 0 and 8 weeks.	8 weeks	No
Primary	Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire	Change in score between 0 and 8 weeks.	8 weeks	No
Secondary	Hospital Anxiety and Depression Scale (HADS)	Change in score between 0 and 8 weeks.	8 weeks	No

External Links

•   Website directing to project description and updates