NCT01943656

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 17, 2013

Status Verified

September 1, 2013

Enrollment Period

6 months

First QC Date

July 22, 2013

Last Update Submit

September 12, 2013

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

  • Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire

    Change in score between 0 and 8 weeks.

    8 weeks

Secondary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

    8 weeks

Other Outcomes (1)

  • Assistive Technology Device Predisposition Assessment© (ATDPA) Questionnaire

    8 weeks

Study Arms (1)

Tobii™ Eyegaze System

EXPERIMENTAL

Single arm, open label study.

Device: Tobii™ Eyegaze System

Interventions

Tobii™ Eyegaze SystemDEVICE

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.

Also known as: Eyegaze System, Eye-tracking Operation System
Tobii™ Eyegaze System

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Spinal Injuries Centre, Stoke Mandeville Hospital

Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Joost J. van Middendorp, MD, PhD

    Stoke Mandeville Spinal Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost J. van Middendorp, MD, PhD

CONTACT

+44 1296316783Joost.vanMiddendorp@buckshealthcare.nhs.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

September 17, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 17, 2013

Record last verified: 2013-09

Locations

GB(1)