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Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors (c-SIGHT)

Primary Purpose

Stroke, Brain Injuries, Spatial Neglect

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
c-SIGHT (computorized spatial innatention grasping home-based therapy)
Sponsored by
University of East Anglia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Telerehabilitation, Spatial neglect, SIGHT, Computorized therapy, Stroke, Innatention, Self-admnistered therapy, Usability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of East AngliaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

c-SIGHT

Arm Description

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

Outcomes

Primary Outcome Measures

Behavioral Inattention Test (BIT) conventional sub tests
Standardized measure of spatial inattention

Secondary Outcome Measures

Line bisection Test
Test for spatial inattention which measures spatial biases when marking middle of 10 20mm lines. Bisection error bigger that 6mm is considered evidence of spatial inattention.
Broken Hearts test from Oxford Cognitive Screening (paper version)
Standardized measure of spatial inattention
Computerized extrapersonal neglect test (CENT)
Computerized test measuring ego and allocentric neglect sub types in extra personal space via television screen
Catherine Bergego Scale
Standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations. The scale also measures self-awareness of behavioral neglect (anosognosia). The CBS uses a 4-point rating scale to indicate the severity of neglect for each item: 0 = no neglect = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side) = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions) = severe neglect (patient is only able to explore the right hemispace) This results in a total score out of 30. Azouvi et al. (2002, 2003) have reported arbitrary ratings of neglect severity according to total scores: 0 = No behavioral neglect 1-10 = Mild behavioral neglect 11-20 = Moderate behavioral neglect 21-30 = Severe behavioral neglect
Pinch and grip force task (dynamometer)
Measures upper limb function
Caregiver Burden Scale
To assess perceived burden among people caring for others with disabilities. There are 22 items in which the carer rates perceived burden from 0 (never) to 4 (nearly always). A total score of 0 to 20 = little or no burden; 21 to 40 = mild to moderate burden; 41 to 60 = moderate to severe burden; 61 to 88 = severe burden.
Stroke Specific Quality of Life Scale (SS-QOL)
A patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning. The SS-QOL yields both domain scores and an overall SS-QOL summary score. The domain scores are unweighted averages of the associated items while the summary score is an unweighted average of all twelve domain scores.

Full Information

First Posted
May 20, 2019
Last Updated
August 7, 2019
Sponsor
University of East Anglia
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03963661
Brief Title
Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors
Acronym
c-SIGHT
Official Title
Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
April 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of East Anglia
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Injuries, Spatial Neglect, Attention Deficit
Keywords
Telerehabilitation, Spatial neglect, SIGHT, Computorized therapy, Stroke, Innatention, Self-admnistered therapy, Usability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
c-SIGHT
Arm Type
Experimental
Arm Description
SIGHT requires participants to grasp and lift rods with their less impaired arm.
Intervention Type
Behavioral
Intervention Name(s)
c-SIGHT (computorized spatial innatention grasping home-based therapy)
Other Intervention Name(s)
visuomotor feedback training
Intervention Description
C-SIGHT will be self-administered at people's homes. c-SIGHT is a computerized therapy administered via people's television. The therapy involves performing repeated rod lifts with the less impaired arm in response to auditory and visual instructions presented on the television screen connected to a laptop. A small motion-tracking camera monitors rod lifts during therapy sessions. People will be asked to self-administer c-SIGHT for 1 hour a day (30min after breakfast and 30min after lunch) for 7 consecutive days. The first day of therapy will be performed with a therapist there for training purposes.
Primary Outcome Measure Information:
Title
Behavioral Inattention Test (BIT) conventional sub tests
Description
Standardized measure of spatial inattention
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Secondary Outcome Measure Information:
Title
Line bisection Test
Description
Test for spatial inattention which measures spatial biases when marking middle of 10 20mm lines. Bisection error bigger that 6mm is considered evidence of spatial inattention.
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Broken Hearts test from Oxford Cognitive Screening (paper version)
Description
Standardized measure of spatial inattention
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Computerized extrapersonal neglect test (CENT)
Description
Computerized test measuring ego and allocentric neglect sub types in extra personal space via television screen
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Catherine Bergego Scale
Description
Standardized checklist to detect presence and degree of unilateral neglect during observation of everyday life situations. The scale also measures self-awareness of behavioral neglect (anosognosia). The CBS uses a 4-point rating scale to indicate the severity of neglect for each item: 0 = no neglect = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side) = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions) = severe neglect (patient is only able to explore the right hemispace) This results in a total score out of 30. Azouvi et al. (2002, 2003) have reported arbitrary ratings of neglect severity according to total scores: 0 = No behavioral neglect 1-10 = Mild behavioral neglect 11-20 = Moderate behavioral neglect 21-30 = Severe behavioral neglect
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Pinch and grip force task (dynamometer)
Description
Measures upper limb function
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Caregiver Burden Scale
Description
To assess perceived burden among people caring for others with disabilities. There are 22 items in which the carer rates perceived burden from 0 (never) to 4 (nearly always). A total score of 0 to 20 = little or no burden; 21 to 40 = mild to moderate burden; 41 to 60 = moderate to severe burden; 61 to 88 = severe burden.
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Title
Stroke Specific Quality of Life Scale (SS-QOL)
Description
A patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items in 12 domains. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning. The SS-QOL yields both domain scores and an overall SS-QOL summary score. The domain scores are unweighted averages of the associated items while the summary score is an unweighted average of all twelve domain scores.
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Other Pre-specified Outcome Measures:
Title
System Usability Scale
Description
To assess usability of devices and applications. Participants are asked to score the following 10 items with one of five responses that range from Strongly Agree to Strongly disagree. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. Though the scores are 0-100, these are not percentages and should be considered only in terms of their percentile ranking. Based on research, a SUS score above a 68 would be considered above average and anything below 68 is below average.
Time Frame
immediately after 7 days of therapy (T2)
Title
Semi-structured interview at end of study with carer and stroke survivor
Description
To assess usability (qualitative data)
Time Frame
immediately after 7 days of therapy (T2)
Title
WAIS Digit span (control measure)
Description
Digit span from WAIS (forward, backward and sequential) is used as a control task
Time Frame
Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Rossit, Ph.D
Phone
+44 (0)160359 1674
Email
s.rossit@uea.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Pomeroy, Ph.D
Phone
+44 (0)1603 59 1668
Email
v.pomeroy@uea.ac.uk
Facility Information:
Facility Name
University of East Anglia
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7TJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Rossit, PhD
First Name & Middle Initial & Last Name & Degree
Stephanie Rossit
First Name & Middle Initial & Last Name & Degree
Valerie Pomeroy
First Name & Middle Initial & Last Name & Degree
Amy Jolly
First Name & Middle Initial & Last Name & Degree
Helen Morse

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28116988
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.
Results Reference
background
Links:
URL
http://www.sight.uea.ac.uk
Description
SIGHT website

Learn more about this trial

Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors

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