- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04752982
Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes? (c-SIGHT)
A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stephanie Rossit, PhD
- Phone Number: 0160359 1674
- Email: s.rossit@uea.ac.uk
Study Contact Backup
- Name: Helen Morse
- Email: helen.morse@uea.ac.uk
Study Locations
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Cambridge, United Kingdom
- Recruiting
- Cambridge university hospital
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Contact:
- Elaine Amis
- Email: elaine.amis@addenbrookes.nhs.uk
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Cambridge, United Kingdom
- Active, not recruiting
- Cambridgeshire and Peterborough Nhs Foundation Trust
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Norwich, United Kingdom
- Recruiting
- Norfolk & Norwich University Hospital NHS Foundation Trust
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Contact:
- Kneale Metcalf
- Email: kneale.metcalf@nnuh.nhs.uk
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Norwich, United Kingdom
- Recruiting
- Norfolk Community Health and Care NHS Trust
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Contact:
- Nicky Sweeting
- Email: Nicky.Sweeting@nchc.nhs.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Stroke survivors meeting all of the following criteria (and none of the exclusion criteria) at screening will be eligible to take part:.
- 18 years and older
- At least one-week post-stroke
- Stroke confirmed using clinical neuroimaging (head CT or MRI)
- Medically stable (as confirmed by the stroke service medical team responsible for the individual's stroke care)
- Capacity to give informed consent (as confirmed by the stroke service medical team responsible for the individual's stroke care and/or PI)
- Able to follow and execute a two-step command (e.g. "lift and balance this pen/pencil")
- Live within 70 miles of the University of East Anglia
- Signs of spatial neglect either via clinical assessment (e.g. star cancellation test; BIT) or observation
Exclusion criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: c-SIGHT intervention
Grasp, lift and balance three wooden rods of different lengths.
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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).
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Sham Comparator: c-SIGHT attentional control
Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: Through study completion, approximately 2 years
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Rate of participants recruited into the trial amongst all participants screened
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Through study completion, approximately 2 years
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Exclusion rate
Time Frame: Through study completion, approximately 2 years
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Rate of participants excluded from participating amongst all participants screened
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Through study completion, approximately 2 years
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Attrition rate
Time Frame: Through study completion, approximately 2 years
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Rate of participants and data lost
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Through study completion, approximately 2 years
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Follow-up rate
Time Frame: Through study completion, approximately 2 years
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Rate of participants included at follow-up
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Through study completion, approximately 2 years
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Time required to collect and analyze data
Time Frame: Through study completion, approximately 2 years
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Time required for data collection and analysis will be computed per participant.
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Through study completion, approximately 2 years
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c-SIGHT compliance
Time Frame: 10 days
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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.
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10 days
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Blinding and allocation success
Time Frame: Through study completion, approximately 2 years
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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.
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Through study completion, approximately 2 years
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Adherence to c-SIGHT protocol
Time Frame: Through study completion, approximately 2 years
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The number of trials performed and length will be computed per session via a motion-tracking sensor.
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Through study completion, approximately 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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. |
Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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Oxford Cognitive Screen
Time Frame: Baseline (T0, before intervention)
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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.
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Baseline (T0, before intervention)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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.
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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).
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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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)
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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).
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Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
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Rates of clinical brain scans obtained
Time Frame: Through study completion, approximately 2 years
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Number of clinical scans obtained.
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Through study completion, approximately 2 years
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System Usability Scale
Time Frame: Post-training (T1, after 10 days of intervention)
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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.
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Post-training (T1, after 10 days of intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephanie Rossit, Ph.D, University of East Anglia
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.
- Morse 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R207146
- SA PGF 19/100016 (Other Grant/Funding Number: Stroke Association)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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