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

NCT03963661 | Unknown

• 1 other identifier: R206721
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Injuries; Spatial Neglect; Attention Deficit

Keywords

Telerehabilitation; Spatial neglect; SIGHT; Computorized therapy; Stroke; Innatention; Self-admnistered therapy; Usability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

Other Outcomes (3)

• System Usability Scale

  immediately after 7 days of therapy (T2)

• Semi-structured interview at end of study with carer and stroke survivor

  immediately after 7 days of therapy (T2)

• WAIS Digit span (control measure)

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

Study Arms (1)

c-SIGHT

EXPERIMENTAL

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

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

Interventions

c-SIGHT (computorized spatial innatention grasping home-based therapy) BEHAVIORAL

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.

Also known as: visuomotor feedback training

c-SIGHT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +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

Sponsors & Collaborators

• University of East Anglia: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR4 7TJ, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 28116988 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Stephanie Rossit, Ph.D

CONTACT

+44 (0)160359 1674; s.rossit@uea.ac.uk

Valerie Pomeroy, Ph.D

CONTACT

+44 (0)1603 59 1668; v.pomeroy@uea.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 28, 2019
• Study Start: May 6, 2019
• Primary Completion: February 1, 2020
• Study Completion: April 3, 2020
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)