Wearable technology in post breast surgery upper limb rehabilitation
| ISRCTN | ISRCTN24248527 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24248527 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 327556 |
| Protocol serial number | 23CX8516 |
| Sponsor | Imperial College London |
| Funders | Imperial MedTechOne, Wellcome Trust |
- Submission date
- 27/03/2025
- Registration date
- 12/04/2025
- Last edited
- 05/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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?
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?
November 2024 to August 2025
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomized prospective parallel group non-blinded trial |
| Secondary study design | Randomised parallel trial |
| Study type | 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | OnTrack Rehab |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 04/08/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 56 |
| Total final enrolment | 70 |
| 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
- United Kingdom
- England
Study participating centre
London
W6 8RF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/09/2025: The following changes were made to the trial record:
1. The completion date was changed from 30/09/2025 to 04/08/2025.
2. The total final enrolment was added.
28/03/2025: Trial's existence confirmed by London - Surrey Research Ethics Committee.
