Status:
UNKNOWN
Can we Use c-SIGHT for Spatial Neglect in Stroke Survivors' Homes?
Lead Sponsor:
University of East Anglia
Collaborating Sponsors:
Norwich Clinical Trials Unit, UK
The Stroke Association, United Kingdom
Conditions:
Stroke
Spatial Neglect
Eligibility:
All Genders
18+ years
Phase:
NA
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 effecti...
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: ac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04752982
Start Date
February 25 2021
End Date
September 30 2022
Last Update
July 12 2021
Active Locations (4)
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1
Cambridge University Hospital
Cambridge, United Kingdom
2
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge, United Kingdom
3
Norfolk & Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom
4
Norfolk Community Health and Care NHS Trust
Norwich, United Kingdom