Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes?

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)

Conditions
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Inattention, Stroke, Spatial Neglect

Intervention / Treatment
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* Behavioral: c-SIGHT intervention
* Behavioral: c-SIGHT attentional control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: c-SIGHT intervention<br>Grasp, lift and balance three wooden rods of different lengths. | Behavioral: c-SIGHT intervention<br>* 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).<br>|
| Sham Comparator: c-SIGHT attentional control<br>Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods). | Behavioral: c-SIGHT attentional control<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Rate of participants recruited into the trial amongst all participants screened | Through study completion, approximately 2 years | 
| Exclusion rate | Rate of participants excluded from participating amongst all participants screened | Through study completion, approximately 2 years | 
| Attrition rate | Rate of participants and data lost | Through study completion, approximately 2 years | 
| Follow-up rate | Rate of participants included at follow-up | 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. | 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. | 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. | 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. | Through study completion, approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | Post-training (T1, after 10 days of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Spatial Neglect, c-SIGHT, Feasibility Trial, Telerehabilition, Home-based therapy, Attention