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)
2 other identifiers
interventional
46
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Feb 2021
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJuly 12, 2021
July 1, 2021
1.6 years
February 7, 2021
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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 Outcomes (15)
Star cancellation test
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
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)
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
Baseline (T0, before intervention)
Broken Hearts test
Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
- +10 more secondary outcomes
Study Arms (2)
c-SIGHT intervention
ACTIVE COMPARATORGrasp, lift and balance three wooden rods of different lengths.
c-SIGHT attentional control
SHAM COMPARATORGrasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods).
Interventions
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).
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).
Eligibility Criteria
You may not qualify if:
- 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
- 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)
- years and older
- Capacity to give informed consent
- Carer of stroke survivor in trial
- Live within 70 miles of the University of East Anglia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of East Anglialead
- Norwich Clinical Trials Unit, UKcollaborator
- The Stroke Association, United Kingdomcollaborator
Study Sites (4)
Cambridge University Hospital
Cambridge, United Kingdom
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge, United Kingdom
Norfolk & Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
Norfolk Community Health and Care NHS Trust
Norwich, United Kingdom
Related Publications (2)
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.
PMID: 28116988BACKGROUNDMorse 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.
PMID: 32942950BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie Rossit, Ph.D
University of East Anglia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer
Study Record Dates
First Submitted
February 7, 2021
First Posted
February 12, 2021
Study Start
February 25, 2021
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
July 12, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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.
The final anonymised data set will be shared with other researchers through an open repository.