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

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ClinicalTrials.gov Identifier: NCT03963661
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : August 12, 2019
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Stephanie Rossit, University of East Anglia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stroke Brain Injuries Spatial Neglect Attention Deficit Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study
Actual Study Start Date : May 6, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : April 3, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: c-SIGHT
SIGHT requires participants to grasp and lift rods with their less impaired arm.
 Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)
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.
Other Name: visuomotor feedback training


Outcome Measures
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Primary Outcome Measures :
  1. Behavioral Inattention Test (BIT) conventional sub tests [ Time Frame: 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


Secondary Outcome Measures :
  1. Line bisection Test [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]
    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.

  2. Broken Hearts test from Oxford Cognitive Screening (paper version) [ Time Frame: 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

  3. Computerized extrapersonal neglect test (CENT) [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]
    Computerized test measuring ego and allocentric neglect sub types in extra personal space via television screen

  4. Catherine Bergego Scale [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]

    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

    1. = mild neglect (patient always explores the right hemispace first and slowly or hesitantly explores the left side)
    2. = moderate neglect (patient demonstrates constant and clear left-sided omissions or collisions)
    3. = 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


  5. Pinch and grip force task (dynamometer) [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]
    Measures upper limb function

  6. Caregiver Burden Scale [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]

    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.


  7. Stroke Specific Quality of Life Scale (SS-QOL) [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]
    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.


Other Outcome Measures:
  1. System Usability Scale [ Time Frame: immediately after 7 days of therapy (T2) ]

    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.


  2. Semi-structured interview at end of study with carer and stroke survivor [ Time Frame: immediately after 7 days of therapy (T2) ]
    To assess usability (qualitative data)

  3. WAIS Digit span (control measure) [ Time Frame: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2) ]
    Digit span from WAIS (forward, backward and sequential) is used as a control task


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963661


Contacts
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Contact: Stephanie Rossit, Ph.D +44 (0)160359 1674 s.rossit@uea.ac.uk
Contact: Valerie Pomeroy, Ph.D +44 (0)1603 59 1668 v.pomeroy@uea.ac.uk

Locations
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United Kingdom
University of East Anglia Recruiting
Norwich, Norfolk, United Kingdom, NR4 7TJ
Contact: Stephanie Rossit, PhD         
Principal Investigator: Stephanie Rossit         
Sub-Investigator: Valerie Pomeroy         
Sub-Investigator: Amy Jolly         
Sub-Investigator: Helen Morse         
Sponsors and Collaborators
University of East Anglia
National Institute for Health Research, United Kingdom
More Information
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Additional Information:

Publications:

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Responsible Party: Stephanie Rossit, Principal Investigator, University of East Anglia
ClinicalTrials.gov Identifier: NCT03963661    
Other Study ID Numbers: R206721
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: August 12, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Rossit, University of East Anglia:
Telerehabilitation
Spatial neglect
SIGHT
Computorized therapy
 Stroke
Innatention
Self-admnistered therapy
Usability
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System