The RenAtt Method for Diagnosing and Treating Attention Problems After Stroke and Brain Injury, Further Validation of RehAtt® DiSTRO Assessment of Cognitive and Visual Function

Summary

Stroke is one of the most common long-term disabilities in the world. Despite better access to more effective acute treatment, WHO reports a prediction of almost a doubling of disability-adjusted life-years (DALYs) in 2050. In UK about 100 000, in Sweden about 20,000 people suffer a stroke yearly. Cognitive effects after a stroke are issues with the way the brain understands, organises and records information. An overwhelming majority of stroke survivors, and their care givers, report on how these problems are profoundly disabling and their greatest concern. In a survey where more than 10,000 stroke survivors were asked about lived experience after stroke, more than nine out of ten reports on experiences from at least one cognitive domain, such as problems with attention or memory. The prevalence reported varies deeply, depending upon screening methods, severity, and timing after stroke. Prevalence in the acute phase ranges from 49-92%, and at follow-up after 6-12 months, 41-57% The high prevalence of cognitive deficits following stroke and their impact on patients' recovery strongly indicates the value of cognitive screening early after stroke as recommended in clinical guidelines. For the patients and their care givers, it is important to be informed early on about a sudden loss of function has a value to gain insight and be motivated for rehabilitation. The Oxford Cognitive Screen (OCS) is a recommended, first-line cognitive screening designed for use in stroke patients in several international guidelines. For implementation in Sweden a Swedish translation, cultural adaptation and validation was requested. In UK and Italy OCS is recommended in clinical guidliens and broadly used and implemented in paper based form. A challenge to implement OCS is that is time and resourse consuming, about 20 to 60 minutes (preparation, performance of test, scoring and interpretation of results).Following recommendations to use digital health technologies to improve screening efficiency, a tablet OCS was designed and developed. This study includes an equivalence testing of the paper to tablet OCS versions, in subacute stroke and healthy, in UK, Sweden and Italy. Method: The OCS was translated into Swedish following a standardised forward-backward translation process with expert review, to ensure linguistic and cultural accuracy. A digital tablet based version of the OCS was developed and validated. Subacute stroke survivors were assessed with the paper and tablet versions of the OCS-SE (A/B), in a randomised counterbalanced order, assessors blinded to allocation. Normative data were collected from 100 healthy with both methods in Sweden. Further equvalence testing of OCS paper-version to tablet-version was performed in 50 stroke and 100 healthycontrols in Italy and 50 stroke and 100 healthy controls in UK. Performance was compared across modalities using equivalence t-tests to assess the consistency of results. The study validating the tablet OCS was made to improve idenitifcation of cognitive impairments after stroke, to improve accuracy of results, by its computerised support in standardising the procedure, providing continuous access to instructions and the automatic scoring.

Conditions

• Stroke
• Cognitive and Attention Disorders and Disturbances
• Digital Health
• Screening Strategy

Interventions

DIAGNOSTIC_TEST

Oxford Cognitive Screen

tablet based version of the Oxford Cognitive Screen

Sponsors & Collaborators

• Department of clinical sciences at Danderyd hospital

  collaborator UNKNOWN

• Umeå University

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-03-27

Primary Completion

2025-08-01

Completion

2025-08-01

Countries

• Italy
• Sweden
• United Kingdom

Study Locations