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

NCT07762274 | Completed

• 2 other identifiers: Dnr 2025-00224-02IRAS project ID: 347730
• Study Type: observational
• Target: 450
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

tablet based Oxford Cognitive Screening; digital tools; cognitive impairments after stroke

Outcome Measures

Primary Outcomes (2)

• Equvalience testing tablet to paper versions of Oxford Congitive Screen

  Data analysis First, to established demographic details for the samples and compared these to the original UK normative data. Then to examined performance on the paper OCS and the tablet OCS and then explored age and education effects on performance. To establishe the internal consistency of each subtest in the tablet OCS, and alternative forms' reliability between version A and B of the tablet OCS. Following this, to examine equivalence between the tablet OCS and paper OCS and presented normative data for version A and B of the tablet OCS. For comparison, use equivalence t-tests, ANOVA, Chi-Squared tests, Fischer Exact tests, or Kruskal-Wallis Rank Sum Test and Mann-Whitney U tests where assumptions permitted, via the package table one version 0.13.2 (P\<0,05)

  one year

• equiveillance between electronic OCS and paper-based OCS, parametric or non-parametric analyses techniques to establish the association between electronic and paper-based OCS

  Spearman's Rho correlations, proportions of tasks impaired across versions, and two-sided tests of equivalence methods will be used.

  6 month

Study Arms (1)

stroke survivors in subacute phase and healthy controls

150 stroke ( 50 in UK, 50 in Italy, 50 in Sweden) who within 2-weeks after stroke admitted to Hospital, either the hyper acute or acute stroke wards. The sample size was chosen based on the planned analyses and the number of participants required to accurately conduct these tests. Confirmed stroke via neuroimaging and/or clinical diagnosis, Aged 18 years or older, Within 48hrs or up to 2-week of confirmed clinical diagnosis of stroke (first ever or recurrent) Ability to concentrate for 10 minutes, as judged by clinical team, Sufficient English/Italien/Swedish/ fluency. Able and willing to provide informed consent Exclusion criteria Any sensory or perception impairments (e.g., vision or hearing) which preclude the administration of OCS 2) Any medical or psychiatric conditions or delirium that makes cognitive assessments in appropriate in the 3-day timeframe. Severe receptive aphasia (no reliable yes/no responses (\<95% correct response.

Diagnostic Test: Oxford Cognitive Screen

Interventions

Oxford Cognitive Screen DIAGNOSTIC_TEST

tablet based version of the Oxford Cognitive Screen

stroke survivors in subacute phase and healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke and healthy control se above

You may qualify if:

• Confirmed stroke via neuroimaging and/or clinical diagnosis
• Aged 18 years or older
• Within 48hrs or up to 2-week of confirmed clinical diagnosis of stroke (first ever or recurrent) 4) Ability to concentrate for 10 minutes, as judged by clinical team

You may not qualify if:

• Any sensory or perception impairments (e.g., vision or hearing) which preclude the administration of OCS even with reasonable adjustments
• Any medical or psychiatric conditions or delirium that makes cognitive assessments in appropriate in the 3-day timeframe
• Severe receptive aphasia (no reliable yes/no responses (\<95% correct response)

Sponsors & Collaborators

• Umeå University: lead
• Department of clinical sciences at Danderyd hospital: collaborator

Study Sites (3)

Physical and Rehabilitative Medicine Unit, South-East Tuscany Regional Health Service

Grosseto, Tuscany, 58100, Italy

Location

Danderyd University Hospital, Stockholm, Sweden

Danderyd, Stockholm County, 18288, Sweden

Location

St George's Hospital, St Georges Hospitals NHS Foundation Trust

London, England, SW17 0QT, United Kingdom

Location

Related Publications (1)

• Tablet Oxford Cognitive Screen from Analogue to Digital: Equivalence Testing in UK, Sweden and Italy" (ESOC2026A1333), in the European Stroke Journal. Published on May 6, 2026,

  RESULT

MeSH Terms

Conditions

Stroke; Cognition Disorders

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, neurologist , Stroke Physician

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: August 13, 2026
• Study Start: March 27, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: April 2026 April 2028
• Access Criteria: Contact with Helena Fordell

Locations

SE (1); IT (1); GB (1)