Wearable technology in post breast surgery upper limb rehabilitation
| ISRCTN | ISRCTN24248527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24248527 |
| IRAS number | 327556 |
| Secondary identifying numbers | 23CX8516 |
- Submission date
- 27/03/2025
- Registration date
- 12/04/2025
- Last edited
- 09/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Breast cancer is the most common cancer worldwide, with over 55,000 patients diagnosed in the UK each year. Axillary surgery, which includes procedures like Sentinel Lymph Node Biopsy (SNLB) and Axillary Node Dissection (AND), is crucial for staging breast cancer but can lead to shoulder problems such as pain, reduced movement, lymphoedema, and decreased quality of life. This study aims to explore the benefits of a digital rehabilitation system called OnTrack, which uses a smartwatch and smartphone to help breast cancer patients recover arm function after surgery.
Who can participate?
Adults aged 18 and older who are scheduled for sentinel node biopsy or axillary node clearance as part of their breast cancer treatment can participate. Participants must be able to provide informed consent.
What does the study involve? (for participants)
Participants will use the OnTrack system, which provides real-time activity feedback and remote physiotherapy support through a smartwatch and smartphone. This system is designed to help manage arm rehabilitation effectively.
What are the possible benefits and risks of participating?
Benefits include reduced pain and lymphoedema, improved shoulder mobility, and enhanced quality of life. The study also aims to generate cost savings for patients. Risks may include mild discomfort from using the wearable devices, but these are expected to be minimal.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
---
Who is funding the study?
Imperial MedTechOne (UK)
Wellcome Trust (UK)
Who is the main contact?
Ahmed Latif, ahmed.latif@imperial.ac.uk
Daniel Leff, d.leff@imperial.ac.uk
Contact information
Public, Scientific
10th Floor QEQM Building
St Mary's Hospital
London
W2 1NY
United Kingdom
 ORCID ID |
0009-0001-9066-813X |
|---|---|
| Phone | +44 7903292540 |
| ahmed.latif@imperial.ac.uk |
Principal Investigator
Breast Surgery Unit, Charing Cross Hospital
London
W6 8RF
United Kingdom
| Phone | +44 7340102203 |
|---|---|
| d.leff@imperial.ac.uk |
Study information
| Study design | Randomized prospective parallel group non-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | A study to investigate the use of wearable technology in upper limb rehabilitation post breast and axillary surgery |
| Study objectives | Wearable technology can facilitate remote shoulder rehabilitation post breast and axillary surgery. |
| Ethics approval(s) |
Approved 29/02/2024, London - Surrey Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8131; surrey.rec@hra.nhs.uk), ref: 24/PR/0049 |
| Health condition(s) or problem(s) studied | Shoulder disfunction post breast and axillary surgery |
| Intervention | Control Arm: Standard NHS care post breast and axillary surgery. This involves patients receiving an exercise leaflet and asked to perform exercises at home. Some patients will have an inactivated activity monitor on the arm to track their arm movement and some will have no monitor at all. Patients will be followed up for up a minimum of 1 month post surgery. Intervention arm: patients will be asked to wear a wearable rehabilitation platform (OnTrack App on Apple Watch) for a period of 1 month post surgery in addition to the standard NHS care. The App tracks their movement, gives real-time feedback on activity along with push notifications to encourage movement, allowing remote rehabilitation and remote clinician input. They will also be followed up for 1 month. Randomisation will be using block randomisation via the Sealed Envelope online platform. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | OnTrack Rehab |
| Primary outcome measure | 1. Patient perceptions, satisfaction and acceptability regarding the use of OnTrack measured using semi-structured interviews and a System Usability Scale at the end of the study period. 2. The effect of OnTrack on post-operative upper limb pain measured using validated pain analogue scale at baseline and 1 month after surgery. 3. The effect of OnTrack on post-operative upper-limb movement in the affected limb measured using patient reported outcome measures (DASH questionnaire) along with range of movement, using a goniometer and upper limb strength using a dynamometer, at baseline and 1 month after surgery. 4. The effect of OnTrack on patient's post operative health related quality of life measured using EQ5D5L QoL questionnaire at baseline and 1 month post surgery |
| Secondary outcome measures | 1. Healthcare professionals' (surgeons, nurse specialists and physiotherapists) perceptions and acceptability regarding the use of OnTrack measured using semi-structured interviews at the end of the study period. 2. Impact on the workload of healthcare professionals measured using semi-structured interviews at the end of the study period. |
| Overall study start date | 15/11/2024 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 56 |
| Key inclusion criteria | 1. Age ≥ 18 years 2. Planned for sentinel node biopsy or axillary node clearance as part of their breast cancer management 3. Participants must be able to provide informed consent |
| Key exclusion criteria | 1. Unstable medical condition 2. Pre-existing pre-operative shoulder disability affecting shoulder movement 3. Patients unable to provide informed consent |
| Date of first enrolment | 30/03/2025 |
| Date of final enrolment | 30/06/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London
W6 8RF
United Kingdom
Sponsor information
University/education
Research Governance and Integrity Team
Academic Health Science Centre
Imperial College London and Imperial College Healthcare NHS Trust
Room 221, Level 2, Medical School Building
Norfolk Place
London
W2 1PG
England
United Kingdom
| Phone | +44 2075949832 |
|---|---|
| cheuk-fung.wong@imperial.ac.uk | |
| Website | https://www.imperial.ac.uk |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 01/10/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and or analysed during current study will be available upon request from Ahmed Latif ahmed.latif@imperial.ac.uk |
Editorial Notes
28/03/2025: Trial's existence confirmed by London - Surrey Research Ethics Committee.
