Breast CancerBRACELETNCT03635723
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)
An observational study of Breast Cancer and Mobility Limitation, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Mobility Limitation
- What is being tested?
- Activity monitor
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2018to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing breast surgery.
Who may be able to join
- Breast or axillary surgery
Who cannot join
- Other diagnosed movement disorder
- Cannot consent due to language or capacity
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London, W2 1NY
Richard M Kwasnicki, PhD MRCS, rmk107@ic.ac.uk
Richard M Kwasnicki, PhD MRCS
About this study
This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.
- Conditions
- Breast Cancer, Mobility Limitation
- Being tested
- Activity monitor
- Keywords
- Technology, Rehabilitation, Wearables, Breast surgery, Physical activity, Enhanced recovery after surgery
- Medical subject headings
- Breast Neoplasms, Mobility Limitation, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity monitorDevice
Technology allowing measurement of physical activity
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Having undergone a procedure in hospital Receives: Device: Activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm movements
Arm movements as measured by wearable sensor
Measured: Post-operative for 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start23 Apr 2018
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Kwasnicki, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635723
- Sponsor's protocol ID
- 15/LO/1038 BRACELET
- Acronym
- BRACELET
- Status last verified
- Apr 2024
- First submitted
- 15 Aug 2018
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwasnicki RM, de Galbert L, Poon K, Giannas E, Graham J, Dunne J, Gokani V, Henry FP, Hunter JE, Williams G, Leff D, Wood SH. Validating a digital recovery tool for autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2026 Apr;115:225-233. doi: 10.1016/j.bjps.2026.02.016. Epub 2026 Feb 21.
PubMed 41797200Che Bakri NA, Kwasnicki RM, Giannas E, Dutta T, Hunter JE, Henry FP, Wood S, Ashrafian H, Darzi A, Leff DR. Delineating upper limb longitudinal recovery after simple mastectomy, implant or autologous breast reconstruction using wearable activity monitors. J Plast Reconstr Aesthet Surg. 2025 May;104:113-122. doi: 10.1016/j.bjps.2025.02.012. Epub 2025 Feb 13.
PubMed 40120218
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)
- ClinicalTrials.gov ID
- NCT03635723
- Acronym / sponsor ID
- BRACELET / 15/LO/1038 BRACELET
- Conditions
- Breast Cancer, Mobility Limitation
- Keywords
- Technology, Rehabilitation, Wearables, Breast surgery, Physical activity, Enhanced recovery after surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 17 Aug 2018 (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.
This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Device: Activity monitorHaving undergone a procedure in hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing breast surgery.
Key inclusion criteria (1 listed)
- Breast or axillary surgery
Key exclusion criteria (2 listed)
- Other diagnosed movement disorder
- Cannot consent due to language or capacity
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 |
|---|---|---|
| Activity monitorTechnology allowing measurement of physical activity | Device | Surgical |
Primary outcome
Arm movements
Time frame: Post-operative for 2-4 weeks
Arm movements as measured by wearable sensor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 41797200Kwasnicki RM, de Galbert L, Poon K, Giannas E, Graham J, Dunne J, Gokani V, Henry FP, Hunter JE, Williams G, Leff D, Wood SH. Validating a digital recovery tool for autologous breast reconstruction. J Plast Reconstr Aesthet Surg. 2026 Apr;115:225-233. doi: 10.1016/j.bjps.2026.02.016. Epub 2026 Feb 21.
- Derived from this study: PubMed 40120218Che Bakri NA, Kwasnicki RM, Giannas E, Dutta T, Hunter JE, Henry FP, Wood S, Ashrafian H, Darzi A, Leff DR. Delineating upper limb longitudinal recovery after simple mastectomy, implant or autologous breast reconstruction using wearable activity monitors. J Plast Reconstr Aesthet Surg. 2025 May;104:113-122. doi: 10.1016/j.bjps.2025.02.012. Epub 2025 Feb 13.
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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. This study is not recruiting at the moment.
Richard Kwasnicki principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Mobility Limitation, run by Imperial College London 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard M Kwasnicki, PhD MRCS (+44 (0) 20 759 48904, rmk107@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm movements (time frame: Post-operative for 2-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03635723, which also lists 2 linked publications.
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 11 Apr 2024.