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NCT Number: NCT07560696

Feasibility of Web-based Therapy Sessions

The goal of this feasibility study is to explore rehabilitation outcomes, usability and user experience of a web-based platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders in critical illness and stroke disorders.

The main question it aims to answer is:

" Is it feasible to use a web-based platform for delivering rehabilitation treatment in a large acute National Health Care Organisation"

Participants will undergo therapy sessions prescribed by therapists on a web-based platform instead of the conventional paper-based therapy sessions for their cognitive and speech rehabilitation needs.

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Key information

Conditions

Cognitive Impairment Acquired Brain Injury Brain Diseases Brain Injuries Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Mental Disorders Nervous System Diseases Neurocognitive Disorders Speech Dysfunction Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The population group will be adult patients admitted to critical care unit and stroke unit and diagnosed to have speech and cognitive impairment.

The intervention is to provide therapy prescribed by therapist through Cognishine, a web-based platform instead of paper-based therapy session.

The primary objective is to assess feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting measured by number of completed therapy sessions, per patient days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with cognitive impairment and/or speech impairment being treated at the LUHFT Intensive Care Units and the Stroke wards
  • Need for Cognitive and/or speech and Language rehabilitation

Exclusion criteria

  • Inability to obtain consent
  • Refusal to take part in the study
  • Failure to engage with the Cognishine platform
  • Inability to operate a mobile device/ tablet with support
  • Unavailability of study therapist to provide training of patients
  • Unstable medical condition

Treatment and study plan

a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders

Behavioral

The Cognishine platform is a digital (web-based) general health and wellness monitoring platform. It is designed to support health care professionals specialised in rehabilitation of patients with neurological disorders, through a wide range of multi-media based generalised activities across speech, language, social-emotional, and cognition.

Primary outcomes

  1. To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.

    Time frame: From recruitment until discharge from rehabilitation therapy or discharge from hospital, which ever comes first. Time frames will vary dependent on patient recovery .The anticipated time frame is 1 to 6 months. Maximum follow up is 12 months.

    Total number of completed sessions per patient on the cognishine platform

Secondary outcomes

  1. To assess staff and patient experience of using the Cognishine platform during therapy sessions.

    Time frame: Patients will be asked to complete this on discharge from hospital. Therapists will be asked to complete the questionnaire one month after starting the study (in the middle of recruitment)

    Patients & therapists will be asked to complete the Mobile Health App Usability Questionnaire (MAUQ)for Interactive Mobile Health Apps used by patients.

    The questionnaire is designed and validated to evaluate the usability of interactive health apps from the users perspective.

    The MAUQ questionnaire comprises of 21 questions which cover 3 main usability domains.

    • Ease of use-Navigation, learnability and clarity.
    • Interface and satisfaction-Visual appeal, confidence and overall satisfaction.
    • Usefulness-Perceived value and effectiveness in helping users achieve their health goals.

    Scoring is via a 7 point Likert scale (1 - strongly disagree, 2 - disagree, 3 - somewhat disagree, 4 - neither agree nor disagree, 5 - somewhat agree, 6 -agree, 7 - strongly agree.),with higher scores indicating greater usability and satisfaction.

  2. To generate qualitative data about how to improve the end user experience for therapist to target barriers to implementation

    Time frame: 12 month into the study.

    Focus groups composed of therapists who have used the platform will be asked to provide end user information about using the system. This qualitative data will be used to improve the platform.

  3. To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.

    Time frame: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.

    The Montreal Cognitive Assessment (MoCA) is a standard clinical measurement tool.

    The tool comprises assessment of visuospatial/executive functions ,naming, memory, attention, language ,abstraction and orientation.

    The scoring range is 0-30,with higher scores indicating better cognition, scores of <26 indicating possible cognitive impairment.

    Scores will be collected from clinical notes at initial assessment and at discharge from rehabilitation therapy.

  4. To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.

    Time frame: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months

    The Oxford Cognitive Screen(OCS) is specifically for stroke patients and reduces visual or language bias. It assesses attention, executive function, memory, language, number processing and praxis.

    Each domain is scored with results interpreted as impaired or not impaired. Scores from clinical notes will be collected at initial assessment and at discharge from rehabilitation therapy.

  5. To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.

    Time frame: As recovery is highly individualised time frames will vary amongst participants .It is anticipated that the time frame will range from 1 to 6 months.

    The Orientation log(O-Log) score measures orientation, time place and situation.

    10 items are measured , with each item scoring 0-3.The scoring range is 0-30,with higher scores reflecting better function. Scores <25 indicate disorientation.

    Scores will be collected at initial assessment and at discharge from rehabilitation therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Vinoth Sankar

CONTACT

[email protected]

+044 0151 706 2000

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Collaborators

  • Israel Innovation Authority

Registry information

Official study title

A Feasibility Study to Explore Rehabilitation Outcomes, Usability and User Experience of a Web-Based Platform for Delivering Treatment for Cognitive and Language Impairment Amongst Adults With Acquired Neurological Disorders

Acronym: Cognishine

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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