Strokec-SIGHTNCT04752982
Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes?
A study testing c-SIGHT intervention in people with Stroke and Spatial Neglect, run by University of East Anglia at 4 sites in United Kingdom.
Trial summary
Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world (usually the same side they lost their movement). Currently, there is no effective treatment for spatial neglect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spatial Neglect, Inattention
- What is being tested?
- c-SIGHT intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 25 Feb 2021to 30 Sep 2022
- 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
None listed.
Who cannot join
- History of other neurological conditions (e.g. dementia, brain tumour, Parkinson's disease, previous strokes)
- Bilateral impairment in arms (unable to move both arms)
- Taking part in a stroke rehabilitation research trial (which includes an intervention)
- Carers must meet all the inclusion criteria to take part:
- 18 years and older
- Capacity to give informed consent
- Carer of stroke survivor in trial
- Live within 70 miles of the University of East Anglia
Trial locations and contacts
4 sites in 1 country.
Helen Morse contact
United Kingdom4 sites, 3 recruiting
- Recruiting
Cambridge University Hospital
Cambridge
Elaine Amis, elaine.amis@addenbrookes.nhs.uk
- Active, not recruiting
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge
- Recruiting
Norfolk & Norwich University Hospital NHS Foundation Trust
Norwich
Kneale Metcalf, kneale.metcalf@nnuh.nhs.uk
- Recruiting
Norfolk Community Health and Care NHS Trust
Norwich
Nicky Sweeting, Nicky.Sweeting@nchc.nhs.uk
About this study
Official title: A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world (usually the same side they lost their movement). Currently, there is no effective treatment for spatial neglect. A therapy called SIGHT (Spatial Inattention Grasping Home-based Therapy) has shown early evidence of improving stroke survivors' spatial neglect (Rossit et al., 2019). SIGHT involves individuals picking-up and balance wooden rods with their less affected hand, independently, without the need for a therapist present at all times. Working with stroke survivors, carers and clinicians we have developed of a computerized version of SIGHT (c-SIGHT; Morse et al., in press). The present trial aims to: 1) investigate the feasibility of a blinded randomized controlled trial of c-SIGHT (active intervention) vs. an attentional control training version of c-SIGHT (sham intervention) in the homes of stroke survivors with spatial neglect; 2) Explore participant's experience using c-SIGHT independently at home; and 3) Explore the potential effects and effect size of c-SIGHT active intervention compared to the attentional control training to inform a future Phase II trial.
Read the detailed description
This is a multi-centre, two-arm blinded feasibility clinical trial with an embedded qualitative study. Following baseline assessment, participants will be randomized (using minimization) to either: active vs. sham version of computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT). Randomization and group allocation will be managed and run by Norwich Clinical Trials Unit (independent from research team and outcome assessors). Participants, carers, outcome assessors, clinical care team and research team will be blinded to participant group allocation. Participants allocated to the active intervention c-SIGHT group will be required to lift and balance three wooden rods of different lengths. Those in the attentional control c-SIGHT group will use the same equipment, but will be required to lift the rods from one end only and not attempt to balance them (an attentional control). During the first training session a therapist (independent from the outcome assessors) will set-up the equipment and train the participant to self-administer the relevant version of c-SIGHT independently (i.e., without the presence of a therapist). Following this training session, participants will self-administer the training for 10 consecutive days (thirty-minute sessions 2 times a day - 'Training phase'). On the last day of the training (day 10) the therapist will return to participant's homes to complete a monitoring visit and collect equipment. To monitor adherence and therapy compliance the therapist will collect photos and videos of the first and last session of the training. A blinded assessor will collect outcome assessments at the end of the training phase (T1) and at one-month post-training (T2). The post-training (T1) data collection visit will also include one-to-one semi-structured interviews with stroke survivor participants and their carers (qualitative study).
- Conditions
- Stroke, Spatial Neglect, Inattention
- Being tested
- c-SIGHT intervention, c-SIGHT attentional control
- Keywords
- Stroke, Spatial Neglect, c-SIGHT, Feasibility Trial, Telerehabilition, Home-based therapy, Attention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c-SIGHT interventionBehavioural
The c-SIGHT active intervention involves grasping, lifting and balancing wooden rods using the unaffected hand. C-SIGHT uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop).
c-SIGHT attentional controlBehavioural
The c-SIGHT attentional control exercises involves grasping and lifting wooden rods from one end using the unaffected hand. Identical to the intervention group, the c-SIGHT attentional control version uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop).
| Study group | Role | What they receive |
|---|---|---|
| c-SIGHT intervention | Active comparator | Grasp, lift and balance three wooden rods of different lengths. Receives: Behavioral: c-SIGHT intervention |
| c-SIGHT attentional control | Sham comparator | Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods). Receives: Behavioral: c-SIGHT attentional control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Rate of participants recruited into the trial amongst all participants screened
Measured: Through study completion, approximately 2 years
Exclusion rate
Rate of participants excluded from participating amongst all participants screened
Measured: Through study completion, approximately 2 years
Attrition rate
Rate of participants and data lost
Measured: Through study completion, approximately 2 years
Follow-up rate
Rate of participants included at follow-up
Measured: Through study completion, approximately 2 years
Time required to collect and analyze data
Time required for data collection and analysis will be computed per participant.
Measured: Through study completion, approximately 2 years
c-SIGHT compliance
Measured using short videos of participants carrying out first and final session of c-SIGHT. Following the participant's completion of the trial, videos will be reviewed by the research team to monitor whether participants and therapists deviated from instructions. Photo of set-up of first and last day of the training phase will also be checked to confirm set-up of equipment was correct and constant throughout the training phase.
Measured: 10 days
Blinding and allocation success
Evaluated by the frequency of unblinding occurred among stroke survivors, carers and outcome assessors and clinical care team. Success of allocation method using minimisation will be evaluated by measuring homogeneity of the two groups on co-variates such as age, time since stroke, hemisphere damage and neglect severity.
Measured: Through study completion, approximately 2 years
Adherence to c-SIGHT protocol
The number of trials performed and length will be computed per session via a motion-tracking sensor.
Measured: Through study completion, approximately 2 years
Secondary outcomes (15)
Star cancellation test
The Star Cancellation Test is a paper and pencil test developed to detect the presence of unilateral spatial neglect (USN) in the near extra personal space in patients with stroke.The maximum score that can be achieved on the test is 54 points. A cutoff of < 51 indicates the presence of SN. A Laterality Index or Star Ratio will be calculated from the ratio of stars cancelled on the contralesional side of the page and the total number of stars cancelled. Scores between 0 and 0.46 indicate neglect in the left hemispace. Scores between 0.54 and 1 indicate neglect in the right hemispace.This will be completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Line bisection test
A paper and pencil task that measures spatial biases when marking middle horizontal lines (10 lines of 20 mm length). The deviation in mm from center (bisection error) is averaged and a bisection error > that 6 mm is considered evidence of spatial inattention. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Computerised Extrapersonal Neglect Test (CENT)
Computerised visual search cancellation test and a line bisection test that measure spatial neglect in extra personal space via television screens. Stimuli are presented out of reach (e.g., on participant's television), run on a laptop and performed using a wireless remote. A variety of variables are produced including: total cancelled targets, allocentric and egocentric neglect scores, number of intersections and re-cancellations, quality of search, total time, time asymmetry, asymmetry accuracy, asymmetry search speed and bisection error. Formulas adapted from Dalmaijer et al. (2015). This outcome is completed by stroke survivors only.
Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Oxford Cognitive Screen
The Oxford Cognitive Screen is a short cognitive screening tool specifically designed for stroke survivors inclusive for patients with aphasia and neglect. OCS returns scores and a visual snapshot of a patient's cognitive profile, in a 'wheel of cognition', which at a glance demonstrates the specific cognitive domain impairments in Attention, Language, Praxis, Number and Memory. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention)
Broken Hearts test
Paper-and-pencil standardized measure of spatial neglect (part of Oxford Cognitive Screen). Number of targets and distractors cancelled as well as ego and allocentric scores will be computed. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Stroke Impact Scale (SIS)
The SIS is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional stroke outcomes, including strength, hand function Activities of Daily Living / Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation. An extra question on stroke recovery asks that the client rate on a scale from 0 - 100 how much the client feels that he/she has recovered from his/her stroke. Each item is rated using a 5-point Likert scale. Scoring will be computed for each domain and total according to scoring database: http://www.kumc.edu/school-of-medicine/population-health/research-and-community-engagement/stroke-impact-scale/instructions.html. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Spatial neglect visual analogue scale
A self-rating 10-point scale in which the participant will be asked to mark on a vertical line their (or their loved ones) perceived severity of spatial neglect. Completed by the stroke survivor and carer (if available) separately.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
One item extended test
Observational test of contralesional limb awareness/personal neglect. Participants asked to point with unimpaired arm to six different parts of their body (e.g., ear, shoulder, elbow, side, leg, hand) and receive one of the following scores for each body part: 0 (no movement), 1 (search without reaching), 2 (reaching with hesitation and search), 3 (immediate reaching), with a total score ranging from 0 to 18. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Hand laterality task
Computerized task assessing body representation by testing perception of right vs. left hand images. Reaction times (ms) and errors (e.g., percentage) in identifying hands will be computed. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Body drawing task
Paper-and-pencil task requiring drawing of a person and self. Analysis will involve looking at symmetry of drawing and size/presence of different limbs. Completed by stroke survivors only.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
1:1 semi-structured interview
Completed with the stroke survivor and carer (if available) separately. The interview, lasting approximately 15 minutes, will be transcribed and a thematic analysis will explore the usability of c-SIGHT and provide qualitative data about the therapy.
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Modified Caregiver Strain Index
Questionnaire measuring financial, psychological, social, personal, physical caregiver strain. Carers indicate their agreement to statements from a choice three responses: 'Yes, on a regular basis' (2 points), 'Yes, sometimes' (1 point) and 'No' (0 points). Responses are summed and a higher score indicates greater strain. Completed by carer only (if available).
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Catherine Bergego Scale (CBS) carer version
The Catherine Bergego Scale is a standardized checklist to detect presence and degree of unilateral neglect during everyday life situations. The CBS uses a 4-point rating scale to report the frequency (e.g., Never, occasionally, frequently, always) of each statement occurring (e.g., "Forgets to groom/shave the left/right part of this/her face"). Responses are summed and the maximum score of 30 a total score of 30 indicates severe neglect. Completed by carer only (if available).
Measured: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Rates of clinical brain scans obtained
Number of clinical scans obtained.
Measured: Through study completion, approximately 2 years
System Usability Scale
To assess usability of c-SIGHT. 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 previous research, a SUS score above 68 would be considered above average and anything below 68 is below average. This scale will be completed by the stroke survivor and carer (if available) separately.
Measured: Post-training (T1, after 10 days of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start25 Feb 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly allocated (using minimisation) to either the active intervention or attentional control group. Minimisation will use the following parameters: age, days since stroke, side of hemisphere damaged, and neglect severity (measured using the star cancellation test).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norwich Clinical Trials Unit, UK, The Stroke Association, United Kingdom
- Responsible party
- Principal investigator, Stephanie Rossit, University of East Anglia
- Investigators
- Stephanie Rossit, Ph.D, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752982
- Sponsor's protocol ID
- R207146
- Other IDs
- SA PGF 19/100016
- Acronym
- c-SIGHT
- Status last verified
- Jul 2021
- First submitted
- 7 Feb 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final anonymised data set will be shared with other researchers through an open repository.
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 28116988Morse H, Biggart L, Pomeroy V, Rossit S. Exploring perspectives from stroke survivors, carers and clinicians on virtual reality as a precursor to using telerehabilitation for spatial neglect post-stroke. Neuropsychol Rehabil. 2022 Jun;32(5):707-731. doi: 10.1080/09602011.2020.1819827. Epub 2020 Sep 18.
PubMed 32942950
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
- ClinicalTrials.gov ID
- NCT04752982
- Acronym / sponsor ID
- c-SIGHT / R207146
- Conditions
- Stroke, Spatial Neglect, Inattention
- Keywords
- Stroke, Spatial Neglect, c-SIGHT, Feasibility Trial, Telerehabilition, Home-based therapy, Attention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norwich Clinical Trials Unit, UK, The Stroke Association, United Kingdom
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 12 Feb 2021 (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.
Spatial neglect is a common post-stroke condition in which people may not be aware of anything on one side of the world (usually the same side they lost their movement). Currently, there is no effective treatment for spatial neglect. A therapy called SIGHT (Spatial Inattention Grasping Home-based Therapy) has shown early evidence of improving stroke survivors' spatial neglect (Rossit et al., 2019). SIGHT involves individuals picking-up and balance wooden rods with their less affected hand, independently, without the need for a therapist present at all times. Working with stroke survivors, carers and clinicians we have developed of a computerized version of SIGHT (c-SIGHT; Morse et al., in press). The present trial aims to: 1) investigate the feasibility of a blinded randomized controlled trial of c-SIGHT (active intervention) vs. an attentional control training version of c-SIGHT (sham intervention) in the homes of stroke survivors with spatial neglect; 2) Explore participant's experience using c-SIGHT independently at home; and 3) Explore the potential effects and effect size of c-SIGHT active intervention compared to the attentional control training to inform a future Phase II trial.
Detailed description
This is a multi-centre, two-arm blinded feasibility clinical trial with an embedded qualitative study. Following baseline assessment, participants will be randomized (using minimization) to either: active vs. sham version of computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT). Randomization and group allocation will be managed and run by Norwich Clinical Trials Unit (independent from research team and outcome assessors). Participants, carers, outcome assessors, clinical care team and research team will be blinded to participant group allocation. Participants allocated to the active intervention c-SIGHT group will be required to lift and balance three wooden rods of different lengths. Those in the attentional control c-SIGHT group will use the same equipment, but will be required to lift the rods from one end only and not attempt to balance them (an attentional control). During the first training session a therapist (independent from the outcome assessors) will set-up the equipment and train the participant to self-administer the relevant version of c-SIGHT independently (i.e., without the presence of a therapist). Following this training session, participants will self-administer the training for 10 consecutive days (thirty-minute sessions 2 times a day - 'Training phase'). On the last day of the training (day 10) the therapist will return to participant's homes to complete a monitoring visit and collect equipment. To monitor adherence and therapy compliance the therapist will collect photos and videos of the first and last session of the training. A blinded assessor will collect outcome assessments at the end of the training phase (T1) and at one-month post-training (T2). The post-training (T1) data collection visit will also include one-to-one semi-structured interviews with stroke survivor participants and their carers (qualitative study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly allocated (using minimisation) to either the active intervention or attentional control group. Minimisation will use the following parameters: age, days since stroke, side of hemisphere damaged, and neglect severity (measured using the star cancellation test).
| Arm | Type | Receives |
|---|---|---|
| c-SIGHT intervention | Active comparator | Behavioral: c-SIGHT interventionGrasp, lift and balance three wooden rods of different lengths. |
| c-SIGHT attentional control | Sham comparator | Behavioral: c-SIGHT attentional controlGrasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- History of other neurological conditions (e.g. dementia, brain tumour, Parkinson's disease, previous strokes)
- Bilateral impairment in arms (unable to move both arms)
- Taking part in a stroke rehabilitation research trial (which includes an intervention)
- 18 years and older
- Capacity to give informed consent
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 interventionThe c-SIGHT active intervention involves grasping, lifting and balancing wooden rods using the unaffected hand. C-SIGHT uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop). | Behavioural | c-SIGHT intervention |
| c-SIGHT attentional controlThe c-SIGHT attentional control exercises involves grasping and lifting wooden rods from one end using the unaffected hand. Identical to the intervention group, the c-SIGHT attentional control version uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop). | Behavioural | c-SIGHT attentional control |
Primary outcome
Recruitment rate
Time frame: Through study completion, approximately 2 years
Rate of participants recruited into the trial amongst all participants screened
Exclusion rate
Time frame: Through study completion, approximately 2 years
Rate of participants excluded from participating amongst all participants screened
Attrition rate
Time frame: Through study completion, approximately 2 years
Rate of participants and data lost
Follow-up rate
Time frame: Through study completion, approximately 2 years
Rate of participants included at follow-up
Time required to collect and analyze data
Time frame: Through study completion, approximately 2 years
Time required for data collection and analysis will be computed per participant.
c-SIGHT compliance
Time frame: 10 days
Measured using short videos of participants carrying out first and final session of c-SIGHT. Following the participant's completion of the trial, videos will be reviewed by the research team to monitor whether participants and therapists deviated from instructions. Photo of set-up of first and last day of the training phase will also be checked to confirm set-up of equipment was correct and constant throughout the training phase.
Blinding and allocation success
Time frame: Through study completion, approximately 2 years
Evaluated by the frequency of unblinding occurred among stroke survivors, carers and outcome assessors and clinical care team. Success of allocation method using minimisation will be evaluated by measuring homogeneity of the two groups on co-variates such as age, time since stroke, hemisphere damage and neglect severity.
Adherence to c-SIGHT protocol
Time frame: Through study completion, approximately 2 years
The number of trials performed and length will be computed per session via a motion-tracking sensor.
15 secondary outcomes
Star cancellation test
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Line bisection test
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Computerised Extrapersonal Neglect Test (CENT)
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Oxford Cognitive Screen
Time frame: Baseline (T0, before intervention)
Broken Hearts test
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Stroke Impact Scale (SIS)
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Spatial neglect visual analogue scale
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
One item extended test
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Hand laterality task
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Body drawing task
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
1:1 semi-structured interview
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Modified Caregiver Strain Index
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Catherine Bergego Scale (CBS) carer version
Time frame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
Rates of clinical brain scans obtained
Time frame: Through study completion, approximately 2 years
System Usability Scale
Time frame: Post-training (T1, after 10 days of intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- 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.
- Background: PubMed 32942950Morse H, Biggart L, Pomeroy V, Rossit S. Exploring perspectives from stroke survivors, carers and clinicians on virtual reality as a precursor to using telerehabilitation for spatial neglect post-stroke. Neuropsychol Rehabil. 2022 Jun;32(5):707-731. doi: 10.1080/09602011.2020.1819827. Epub 2020 Sep 18.
- Neurolab page for the trial (news, etc)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The final anonymised data set will be shared with other researchers through an open repository.
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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.
Helen Morse contact
Stephanie Rossit, Ph.D principal investigator
University of East Anglia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing c-SIGHT intervention in people with Stroke and Spatial Neglect, run by University of East Anglia at 4 sites 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 0 inclusion and 8 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 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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, PhD (0160359 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?
Recruitment rate (time frame: Through study completion, approximately 2 years). The study lists 8 primary outcomes in all. 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 NCT04752982, which also lists 2 linked publications.
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 Jul 2021.