Clinical trial NCT03963661: Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors
Official title: Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Brain Injuries
Spatial Neglect
Attention Deficit
Keywords: Telerehabilitation
Spatial neglect
SIGHT
Computorized therapy
Stroke
Innatention
Self-admnistered therapy
Usability
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2019-05-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* +18
* 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

Primary outcomes:
measure: Behavioral Inattention Test (BIT) conventional sub tests
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Secondary outcomes:
measure: Line bisection Test
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Broken Hearts test from Oxford Cognitive Screening (paper version)
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Computerized extrapersonal neglect test (CENT)
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Catherine Bergego Scale
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Pinch and grip force task (dynamometer)
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Caregiver Burden Scale
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
measure: Stroke Specific Quality of Life Scale (SS-QOL)
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Other outcomes:
measure: System Usability Scale
timeFrame: immediately after 7 days of therapy (T2)
measure: Semi-structured interview at end of study with carer and stroke survivor
timeFrame: immediately after 7 days of therapy (T2)
measure: WAIS Digit span (control measure)
timeFrame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
References:
citation: Rossit S, Benwell CSY, Szymanek L, Learmonth G, McKernan-Ward L, Corrigan E, Muir K, Reeves I, Duncan G, Birschel P, Roberts M, Livingstone K, Jackson H, Castle P, Harvey M. Efficacy of home-based visuomotor feedback training in stroke patients with chronic hemispatial neglect. Neuropsychol Rehabil. 2019 Mar;29(2):251-272. doi: 10.1080/09602011.2016.1273119. Epub 2017 Jan 24.