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

University of East Anglia

Status: Unknown

Conditions: Inattention; Spatial Neglect; Stroke

Treatments: Behavioral: c-SIGHT attentional control; Behavioral: c-SIGHT intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04752982

R207146

SA PGF 19/100016 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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46 participants in 2 patient groups

c-SIGHT intervention

Active Comparator group

Description:

Grasp, lift and balance three wooden rods of different lengths.

Treatment:

Behavioral: c-SIGHT intervention

c-SIGHT attentional control

Sham Comparator group

Description:

Grasp and lift three wooden rods of different lengths from one end only (no attempt to balance rods).

Treatment:

Behavioral: c-SIGHT attentional control