Strokec-SIGHTNCT03963661
Investigating Usability of c-SIGHT in the Homes of Brain Injury Survivors
A study testing c-SIGHT (computorized spatial innatention grasping home-based therapy) in people with Stroke and Brain Injuries, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injuries, Spatial Neglect
- What is being tested?
- c-SIGHT (computorized spatial innatention grasping home-based therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 May 2019to 3 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- +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)
Show all 10Show fewer
- mental capacity to consent
- no known learning disability
- no major psychiatric illness
- no history of substance abuse
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of East Anglia
Norwich, Norfolk, NR4 7TJ
Stephanie Rossit, PhD
Stephanie Rossit
About this study
Official title: 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.
- Conditions
- Stroke, Brain Injuries, Spatial Neglect, Attention Deficit
- Being tested
- c-SIGHT (computorized spatial innatention grasping home-based therapy)
- Keywords
- Telerehabilitation, Spatial neglect, SIGHT, Computorized therapy, Stroke, Innatention, Self-admnistered therapy, Usability
- Medical subject headings
- Stroke, Brain Injuries, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-SIGHT (computorized spatial innatention grasping home-based therapy)Behavioural
Also called visuomotor feedback training
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.
| Study group | Role | What they receive |
|---|---|---|
| c-SIGHT | Experimental | SIGHT requires participants to grasp and lift rods with their less impaired arm. Receives: Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Inattention Test (BIT) conventional sub tests
Standardized measure of spatial inattention
Measured: 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
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline (T0) to 7 days (pre-treatment baseline, T1) and from T1 to immediately after 7 days of therapy (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start6 May 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion3 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Stephanie Rossit, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963661
- Sponsor's protocol ID
- R206721
- Acronym
- c-SIGHT
- Status last verified
- Aug 2019
- First submitted
- 20 May 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28116988
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating a Portable Patient-led Virtual Reality Platform for Assessment and Rehabilitation of Hemispatial Neglect: a Usability Study
- ClinicalTrials.gov ID
- NCT03963661
- Acronym / sponsor ID
- c-SIGHT / R206721
- Conditions
- Stroke, Brain Injuries, Spatial Neglect, Attention Deficit
- Keywords
- Telerehabilitation, Spatial neglect, SIGHT, Computorized therapy, Stroke, Innatention, Self-admnistered therapy, Usability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 6 May 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 3 Apr 2020 (estimated)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| c-SIGHT | Experimental | Behavioral: c-SIGHT (computorized spatial innatention grasping home-based therapy)SIGHT requires participants to grasp and lift rods with their less impaired arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- +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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| c-SIGHT (computorized spatial innatention grasping home-based therapy)Also: visuomotor feedback trainingC-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. | Behavioural | c-SIGHT |
Primary outcome
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
7 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 28116988Rossit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing c-SIGHT (computorized spatial innatention grasping home-based therapy) in people with Stroke and Brain Injuries, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Rossit, Ph.D (+44 (0)160359 1674, s.rossit@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.