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

Stroke Clinical Trial

— c-SIGHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04752982
• Other study ID #: R207146
• Secondary ID: SA PGF 19/100016
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2021
• Source: University of East Anglia
• Contact: Stephanie Rossit, PhD
• Phone: 0160359 1674
• Email: s.rossit[@]uea.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inattention
• Perceptual Disorders
• Spatial Neglect
• Stroke

Intervention

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).
• 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).

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (3)

Lead Sponsor	Collaborator
University of East Anglia	Norwich Clinical Trials Unit, UK, The Stroke Association, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. 2020 Sep 18:1-25. doi: 10.1080/09602011.2020.1819827. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Rate of participants recruited into the trial amongst all participants screened	Through study completion, approximately 2 years
Primary	Exclusion rate	Rate of participants excluded from participating amongst all participants screened	Through study completion, approximately 2 years
Primary	Attrition rate	Rate of participants and data lost	Through study completion, approximately 2 years
Primary	Follow-up rate	Rate of participants included at follow-up	Through study completion, approximately 2 years
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Rates of clinical brain scans obtained	Number of clinical scans obtained.	Through study completion, approximately 2 years
Secondary	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)

External Links

•   Link to original non-computorized version of SIGHT materials
•   Neurolab page for the trial (news, etc)