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

NCT ID: NCT04752982

Last Updated: 2021-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-25
• Study Completion Date: 2022-09-30

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).

Conditions

Stroke; Spatial Neglect; Inattention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

c-SIGHT intervention

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

Group Type: ACTIVE_COMPARATOR

c-SIGHT intervention

Intervention Type: BEHAVIORAL

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

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

Group Type: SHAM_COMPARATOR

c-SIGHT attentional control

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwich Clinical Trials Unit, UK

UNKNOWN

Sponsor Role: collaborator

The Stroke Association, United Kingdom

OTHER

Sponsor Role: collaborator

University of East Anglia

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Rossit

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Rossit, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of East Anglia

Locations

Cambridge University Hospital

Cambridge, , United Kingdom

Site Status: RECRUITING

Cambridgeshire and Peterborough NHS Foundation Trust

Cambridge, , United Kingdom

Site Status: ACTIVE_NOT_RECRUITING

Norfolk & Norwich University Hospital NHS Foundation Trust

Norwich, , United Kingdom

Site Status: RECRUITING

Norfolk Community Health and Care NHS Trust

Norwich, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Stephanie Rossit, PhD

Role: CONTACT

s.rossit@uea.ac.uk

0160359 1674

Helen Morse

Role: CONTACT

helen.morse@uea.ac.uk

Facility Contacts

Elaine Amis

Role: primary

elaine.amis@addenbrookes.nhs.uk

Kneale Metcalf

Role: primary

kneale.metcalf@nnuh.nhs.uk

Nicky Sweeting

Role: primary

Nicky.Sweeting@nchc.nhs.uk

References

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.

Reference Type: BACKGROUND

PMID: 28116988 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32942950 (View on PubMed)

Related Links

https://www.stephanierossit.com/c-sight

Neurolab page for the trial (news, etc)

http://www.sight.uea.ac.uk

Link to original non-computorized version of SIGHT materials

Other Identifiers

SA PGF 19/100016

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R207146

Identifier Type: -

Identifier Source: org_study_id