A study of Sensore: continuous pressure monitoring for wheelchair users
| ISRCTN | ISRCTN93859782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93859782 |
| Integrated Research Application System (IRAS) | 365158 |
| National Institute for Health and Care Research (NIHR) | 510280 |
| Sponsor | Graphene Trace Ltd |
| Funder | National Institute for Health and Care Research |
- Submission date
- 22/01/2026
- Registration date
- 23/01/2026
- Last edited
- 23/01/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Pressure ulcers can develop when people sit in the same position for long periods, which is a particular risk for wheelchair users. Sensore is a pressure monitoring system designed to help people understand when pressure is building up and when it may be helpful to change position. The aim of this study is to see whether people can use the Sensore system easily, safely and as intended in everyday situations. The study focuses on usability and acceptability, not on testing health benefits or clinical outcomes.
Who can participate?
Adults aged 18 or over who are wheelchair users, carers of wheelchair users, or healthcare professionals involved in pressure care may be invited to take part. Participants must be able to give informed consent and use a smartphone or tablet.
What does the study involve?
Participants will attend a small number of sessions at a specialist NHS rehabilitation centre. They will be shown how to use the Sensore system and asked to use it while researchers observe. Participants will complete short questionnaires and may take part in interviews or group discussions. Wheelchair users may also use the system at home for a period of time as part of their normal routine. The study does not involve medical treatment or changes to usual care.
What are the possible benefits and risks of participating?
There may be no direct benefit from taking part, but feedback will help improve the design of the Sensore system for future users. Risks are expected to be low and may include mild inconvenience, tiredness, or discomfort from sitting. Participants can stop at any time and can withdraw without giving a reason.
Where is the study run from?
The study is run from the Rehabilitation Engineering Unit at Cardiff and Vale University Health Board (UK).
When is the study starting and how long is it expected to run for?
The study will start on 1st April 2026. Recruitment will take place over several months, and each participant will be involved for up to a few months. The study is expected to run until October 2026.
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) and Graphene Trace Ltd.
Who is the main contact?
The main contact is Stephanie Wentworth, Study Chief Investigator and Principal Clinical Engineer at Cardiff and Vale University Health Board. Contact details will be provided to anyone interested in taking part.
Contact information
Principal investigator, Scientific, Public
Rehabilitation Engineering Unit, ALAS Posture & Mobility Centre
Unit A Taffs Fall Road
Treforest
Pontypridd
CF37 5TF
United Kingdom
 ORCID ID |
0000-0002-9648-1763 |
|---|---|
| Phone | +44 2921833931 |
| stephanie.wentworth@wales.nhs.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Non-interventional summative usability study (human factors evaluation) |
| Scientific title | A summative usability study of Sensore: continuous pressure monitoring for wheelchair users |
| Study objectives | The objective of this study is to evaluate whether intended users can use the Sensore continuous pressure monitoring system safely and effectively under realistic conditions of use. The study aims to assess usability, acceptability, and perceived workload; to identify use-related errors, difficulties and residual risks; and to gather qualitative feedback from wheelchair users, carers and healthcare professionals to inform design refinement, instructions for use and labelling. The study does not assess clinical effectiveness, safety outcomes or changes to usual care and is conducted as a non-interventional summative usability evaluation. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Usability and acceptability of a continuous pressure monitoring system for pressure ulcer risk management in adult wheelchair users and their carers and healthcare professionals. |
| Intervention | This is a single-arm, non-interventional observational study conducted at a single NHS site. Adult wheelchair users, carers and healthcare professionals will participate in clinic-based usability sessions and periods of routine at-home device use. Participants will receive supervised training in device operation and will interact with the Sensore system under realistic conditions of use. Data will be collected through structured observation of critical tasks, validated usability and workload questionnaires, in-depth interviews, focus groups and automatically recorded device telemetry. Data will be analysed descriptively to characterise usability, acceptability, workload and use-related risks. No randomisation, blinding or control group is used, and the study does not alter participants’ usual care. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/10/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Aged 18 years or older. 2. Able and willing to provide informed consent. 3. Adult wheelchair user, carer of a wheelchair user, or healthcare professional involved in pressure care or pressure ulcer prevention. 4. Able to use a smartphone or tablet compatible with the Sensore user interface. 5. Sufficient cognitive and language ability (English or Welsh) to understand study instructions and questionnaires. 6. Willing to participate in clinic-based usability sessions and periods of at-home device use. |
| Key exclusion criteria | 1. Presence of an active pressure ulcer in areas where the sensor would be placed. 2. Prior involvement in the design or development of the Sensore system. 3. Use of bespoke or specialist seating systems incompatible with the Sensore mat. 4. Presence of an implanted or non-removable medical device that may interfere with sensor function. 5. Inability to understand study procedures or instructions for use. 6. Participation in Patient and Public Involvement and Engagement groups associated with this study. |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 30/09/2026 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Treforest
Pontypridd
CF37 5TF
Wales
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Editorial Notes
23/01/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
