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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Brain Injuries; Spatial Neglect; Attention Deficit
• Intervention / Treatment: Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie Rossit, Ph.D; Phone Number: +44 (0)160359 1674; Email: s.rossit@uea.ac.uk
• Study Contact Backup: Name: Valerie Pomeroy, Ph.D; Phone Number: +44 (0)1603 59 1668; Email: v.pomeroy@uea.ac.uk

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7TJ
      • Recruiting
      • University of East Anglia
      • Contact: Stephanie Rossit, PhD
      • Principal Investigator: Stephanie Rossit
      • Sub-Investigator: Valerie Pomeroy
      • Sub-Investigator: Amy Jolly
      • Sub-Investigator: Helen Morse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: visuomotor feedback training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioral Inattention Test (BIT) conventional sub tests	Standardized measure of spatial inattention	Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	Standardized measure of spatial inattention	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)	Computerized test measuring ego and allocentric neglect sub types in extra personal space via television screen	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	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	Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Pinch and grip force task (dynamometer)	Measures upper limb function	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	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.	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)	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.	Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale	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.	immediately after 7 days of therapy (T2)
Semi-structured interview at end of study with carer and stroke survivor	To assess usability (qualitative data)	immediately after 7 days of therapy (T2)
WAIS Digit span (control measure)	Digit span from WAIS (forward, backward and sequential) is used as a control task	Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)

Collaborators and Investigators

• Sponsor: University of East Anglia
• Collaborators: National Institute for Health Research, United Kingdom

Publications and helpful links

General Publications

• 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.

Helpful Links

• SIGHT website

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): April 3, 2020

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 23, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Telerehabilitation; Usability; Spatial neglect; SIGHT; Computorized therapy; Innatention; Self-admnistered therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: R206721

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No