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

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ClinicalTrials.gov Identifier: NCT04752982
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : February 21, 2021
Sponsor:
Collaborators:
Norwich Clinical Trials Unit, UK
The Stroke Association, United Kingdom
Information provided by (Responsible Party):
Stephanie Rossit, University of East Anglia

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Spatial Neglect Inattention Behavioral: c-SIGHT intervention Behavioral: c-SIGHT attentional control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The outcome assessor, stroke survivor, carer, research team and clinical care staff (e.g. GP) will be blinded to group allocation. Participants will not be told if they are in the active or attentional control c-SIGHT group. The set-up and equipment is the same between the two arms and only the instructions differ.
Primary Purpose: Treatment
Official Title: A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
Estimated Study Start Date : February 15, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Active Comparator: c-SIGHT intervention
Grasp, lift and balance three wooden rods of different lengths.
Behavioral: c-SIGHT intervention
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).

Sham Comparator: c-SIGHT attentional control
Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods).
Behavioral: c-SIGHT attentional control
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).




Primary Outcome Measures :
  1. Recruitment rate [ Time Frame: Through study completion, approximately 2 years ]
    Rate of participants recruited into the trial amongst all participants screened

  2. Exclusion rate [ Time Frame: Through study completion, approximately 2 years ]
    Rate of participants excluded from participating amongst all participants screened

  3. Attrition rate [ Time Frame: Through study completion, approximately 2 years ]
    Rate of participants and data lost

  4. Follow-up rate [ Time Frame: Through study completion, approximately 2 years ]
    Rate of participants included at follow-up

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 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) ]
    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.

  2. 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) ]
    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.

  3. 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) ]

    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.


  4. Oxford Cognitive Screen [ Time Frame: Baseline (T0, before intervention) ]
    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.

  5. 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) ]
    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.

  6. 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) ]
    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.

  7. 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) ]
    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.

  8. 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) ]
    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.

  9. 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) ]
    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.

  10. 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) ]
    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.

  11. 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) ]
    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.

  12. 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) ]
    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).

  13. 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) ]
    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).

  14. Rates of clinical brain scans obtained [ Time Frame: Through study completion, approximately 2 years ]
    Number of clinical scans obtained.

  15. System Usability Scale [ Time Frame: Post-training (T1, after 10 days of intervention) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752982


Contacts
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Contact: Stephanie Rossit, PhD 0160359 1674 s.rossit@uea.ac.uk
Contact: Helen Morse helen.morse@uea.ac.uk

Locations
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United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust Not yet recruiting
Norwich, United Kingdom
Contact: Kneale Metcalf         
Norfolk Community Health and Care NHS Trust Recruiting
Norwich, United Kingdom
Contact: Nicky Sweeting         
Sponsors and Collaborators
University of East Anglia
Norwich Clinical Trials Unit, UK
The Stroke Association, United Kingdom
Investigators
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Principal Investigator: Stephanie Rossit, Ph.D University of East Anglia
Additional Information:
Publications:
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Responsible Party: Stephanie Rossit, Lecturer, University of East Anglia
ClinicalTrials.gov Identifier: NCT04752982    
Other Study ID Numbers: R207146
SA PGF 19/100016 ( Other Grant/Funding Number: Stroke Association )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final anonymised data set will be shared with other researchers through an open repository.
Supporting Materials: Study Protocol
Time Frame: Study protocol will be published before or soon after recruitment has begun. The final, anonymised data set will be shared on an open repository (e.g., Open Science Framework) after the study has ended.
URL: https://osf.io/x2jg9/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stephanie Rossit, University of East Anglia:
Stroke
Spatial Neglect
c-SIGHT
Feasibility Trial
Telerehabilition
Home-based therapy
Attention
Additional relevant MeSH terms:
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Stroke
Perceptual Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations