Eyegaze Systems for Spinal Cord Injury: A Feasibility Study
Primary Purpose
Spinal Cord Injury
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Tobii™ Eyegaze System
Sponsored by
About this trial
This is an interventional supportive care trial for Spinal Cord Injury focused on measuring Spinal Cord Injury
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
Sites / Locations
- National Spinal Injuries Centre, Stoke Mandeville Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tobii™ Eyegaze System
Arm Description
Single arm, open label study.
Outcomes
Primary Outcome Measures
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Change in score between 0 and 8 weeks.
Secondary Outcome Measures
Hospital Anxiety and Depression Scale (HADS)
Change in score between 0 and 8 weeks.
Full Information
NCT ID
NCT01943656
First Posted
July 22, 2013
Last Updated
September 12, 2013
Sponsor
Buckinghamshire Healthcare NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT01943656
Brief Title
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
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
February 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buckinghamshire Healthcare NHS Trust
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal Cord Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tobii™ Eyegaze System
Arm Type
Experimental
Arm Description
Single arm, open label study.
Intervention Type
Device
Intervention Name(s)
Tobii™ Eyegaze System
Other Intervention Name(s)
Eyegaze System, Eye-tracking Operation System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire
Description
Change in score between 0 and 8 weeks.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Change in score between 0 and 8 weeks.
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire
Description
Change in score between 0 and 8 weeks.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joost J. van Middendorp, MD, PhD
Phone
+44 1296316783
Email
Joost.vanMiddendorp@buckshealthcare.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
Organizational Affiliation
Stoke Mandeville Spinal Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Spinal Injuries Centre, Stoke Mandeville Hospital
City
Aylesbury
State/Province
Buckinghamshire
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
Phone
+44 1296316783
Email
Joost.vanMiddendorp@buckshealthcare.nhs.uk
First Name & Middle Initial & Last Name & Degree
Joost J. van Middendorp, MD, PhD
First Name & Middle Initial & Last Name & Degree
F Watkins, PhD
First Name & Middle Initial & Last Name & Degree
H Landymore, BSc
First Name & Middle Initial & Last Name & Degree
C Park, BSc, MSc
12. IPD Sharing Statement
Links:
URL
http://www.smsf.org.uk/research%20projects.htm
Description
Website directing to project description and updates
Learn more about this trial
Eyegaze Systems for Spinal Cord Injury: A Feasibility Study
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