Cognitive ImpairmentCognishineNCT07560696
Feasibility of Web-based Therapy Sessions
A study testing a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders in people with Cognitive Impairment and Speech Dysfunction, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Speech Dysfunction, Acquired Brain Injury
- What is being tested?
- a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool University Hospitals NHS Foundation Trust
Liverpool, l7 8xp
Matthew Noonan, +044 0151 706 3734, Matthew.noonan@liverpoolft.nhs.uk
Heather Rogers, +044 0151 706 3702, heather.rogers@liverpoolft.nhs.uk
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders
- Medical subject headings
- Cognitive Dysfunction, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disordersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Web-based patient-led therapy sessions | Experimental | All patients will receive standard of care rehabilitation. In addition, patients recruited into the study will use the Cognishine platform for cognitive and/or language rehabilitation Receives: Behavioral: a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of using the Cognishine web-based platform in a large NHS Trust in acute care setting.
Total number of completed sessions per patient on the cognishine platform
Measured: 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.
Secondary outcomes (5)
To assess staff and patient experience of using the Cognishine platform during therapy sessions.
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.
Measured: 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)
To generate qualitative data about how to improve the end user experience for therapist to target barriers to implementation
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.
Measured: 12 month into the study.
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
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.
Measured: 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.
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
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.
Measured: 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
To generate preliminary data on the rehabilitation progress associated with the use of the Cognishine platform.
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start3 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Israel Innovation Authority
- Responsible party
- Sponsor
- Investigators
- Matthew Noonan, Study chair, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560696
- Sponsor's protocol ID
- LHS0204
- Acronym
- Cognishine
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07560696
- Acronym / sponsor ID
- Cognishine / LHS0204
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Israel Innovation Authority
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based patient-led therapy sessions | Experimental | Behavioral: a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disordersAll patients will receive standard of care rehabilitation. In addition, patients recruited into the study will use the Cognishine platform for cognitive and/or language rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disordersThe 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. | Behavioural | Web-based patient-led therapy sessions |
Primary outcome
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
5 secondary outcomes
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)
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Noonan study chair
Liverpool University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a Web-Based Platform for delivering treatment for cognitive and language impairment amongst adults with acquired neurological disorders in people with Cognitive Impairment and Speech Dysfunction, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinoth Sankar (+044 0151 706 2000, Vinoth.Sankar@liverpoolft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.