Clinical trial NCT04752982: Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes?
Official title: A Feasibility Study of a Computerised Spatial Inattention Grasping Home-based Therapy for Stroke Survivors (c-SIGHT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Spatial Neglect
Inattention
Keywords: Stroke
Spatial Neglect
c-SIGHT
Feasibility Trial
Telerehabilition
Home-based therapy
Attention
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Norwich Clinical Trials Unit, UK
name: The Stroke Association, United Kingdom
First posted: 2021-02-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Through study completion, approximately 2 years
measure: Exclusion rate
timeFrame: Through study completion, approximately 2 years
measure: Attrition rate
timeFrame: Through study completion, approximately 2 years
measure: Follow-up rate
timeFrame: Through study completion, approximately 2 years
measure: Time required to collect and analyze data
timeFrame: Through study completion, approximately 2 years
measure: c-SIGHT compliance
timeFrame: 10 days
measure: Blinding and allocation success
timeFrame: Through study completion, approximately 2 years
measure: Adherence to c-SIGHT protocol
timeFrame: Through study completion, approximately 2 years
Secondary outcomes:
measure: Star cancellation test
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Line bisection test
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Computerised Extrapersonal Neglect Test (CENT)
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Oxford Cognitive Screen
timeFrame: Baseline (T0, before intervention)
measure: Broken Hearts test
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Stroke Impact Scale (SIS)
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Spatial neglect visual analogue scale
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: One item extended test
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Hand laterality task
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Body drawing task
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: 1:1 semi-structured interview
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Modified Caregiver Strain Index
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Catherine Bergego Scale (CBS) carer version
timeFrame: Baseline (T0, before intervention), post-training (T1, after 10 days of intervention) and at follow-up (T2, after 1 month post-training)
measure: Rates of clinical brain scans obtained
timeFrame: Through study completion, approximately 2 years
measure: System Usability Scale
timeFrame: Post-training (T1, after 10 days of intervention)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital
city: Cambridge
country: United Kingdom
facility: Cambridgeshire and Peterborough NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: Norfolk Community Health and Care NHS Trust
Study officials:
affiliation: University of East Anglia
name: Stephanie Rossit, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.