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

NCT ID: NCT03963661

Last Updated: 2019-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-06

Study Completion Date

2020-04-03

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Brain Injuries Spatial Neglect Attention Deficit

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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c-SIGHT

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

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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visuomotor feedback training

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Stephanie Rossit

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of East Anglia

Norwich, Norfolk, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Stephanie Rossit, Ph.D

Role: CONTACT

+44 (0)160359 1674

Valerie Pomeroy, Ph.D

Role: CONTACT

+44 (0)1603 59 1668

Facility Contacts

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Stephanie Rossit, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28116988 (View on PubMed)

Related Links

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Other Identifiers

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R206721

Identifier Type: -

Identifier Source: org_study_id

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