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临床试验/NCT01943656
NCT01943656Unknown4 期

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

Buckinghamshire Healthcare NHS Trust2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
4 期
入组人数
12
试验地点
2
主要终点
Appraisals of Disability: Primary and Secondary Scale (ADAPSS) Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 8 weeks

Change in score between 0 and 8 weeks.

次要结局

  • Hospital Anxiety and Depression Scale (HADS)(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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