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临床试验/NCT03963661
NCT03963661Unknown不适用

Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study

University of East Anglia2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
10
试验地点
2
主要终点
Behavioral Inattention Test (BIT) conventional sub tests

研究概览

简要总结

A brain injury can damage the brain, so that it no longer receives information about the space around one side of the world. If this happens, people may not be aware of anything on one side, usually the same side they also lost their movement (the most affected side). This severe condition is called spatial neglect. Currently there is no recommended diagnostic test or clinically-proven treatment for the condition. In a recent study, the investigators found a long-lasting reduction in neglect if people practiced picking-up an object with their unaffected hand. This intervention is called Spatial Inattention Grasping Home-based Therapy (SIGHT). It requires people to lift wooden rods of different lengths. Once a person is familiar with the task, they can practice on their own at a time convenient to them in their homes. The investigators have developed the first computerized version of SIGHT (c-SIGHT) as well as a novel diagnostic test for neglect using portable low-cost motion-tracking technology that can be used in the patient's home. In the proposed study, the investigators will investigate how usable and acceptable this technology is in people's homes. Stroke survivors (recruited from community settings) will undergo a 7-day self-led training at their homes with c-SIGHT. At the end of the intervention, 1:1 semi-structured interviews will be carried out with both stroke survivors and carers to investigate usability and acceptability of c-SIGHT. Moreover, spatial neglect, carer burden and motor function will be assessed pre- and post-completion of c-SIGHT.

研究设计

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

入排标准

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

入选标准

  • suffered brain injury
  • have TV with around 2 meters in front of it to be able to run the therapy
  • live in the Norfolk, Suffolk, Essex or Cambridgeshire (UK)
  • no other pre-existing neurological disorders (such as dementia)
  • no language impairment (able to follow 1-stage command)
  • mental capacity to consent
  • no known learning disability
  • no major psychiatric illness
  • no history of substance abuse

排除标准

  • 未提供

研究组 & 干预措施

c-SIGHT

Experimental

SIGHT requires participants to grasp and lift rods with their less impaired arm.

干预措施: c-SIGHT (computorized spatial innatention grasping home-based therapy) (Behavioral)

结局指标

主要结局

Behavioral Inattention Test (BIT) conventional sub tests

时间窗: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)

Standardized measure of spatial inattention

次要结局

  • Pinch and grip force task (dynamometer)(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Caregiver Burden Scale(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Broken Hearts test from Oxford Cognitive Screening (paper version)(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Line bisection Test(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Computerized extrapersonal neglect test (CENT)(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Catherine Bergego Scale(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))
  • Stroke Specific Quality of Life Scale (SS-QOL)(Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie Rossit

Principal Investigator

University of East Anglia

研究点 (2)

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