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Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)

Sponsor
Imperial College London (Other)
Overall Status
Unknown status
CT.gov ID
NCT03635723
Collaborator
(none)
75
Enrollment
1
Location
44.3
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)
    Actual Study Start Date :
    Apr 23, 2018
    Anticipated Primary Completion Date :
    Dec 30, 2021
    Anticipated Study Completion Date :
    Dec 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Arm movements [Post-operative for 2-4 weeks]

      Arm movements as measured by wearable sensor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Breast or axillary surgery
    Exclusion Criteria:

    • Other diagnosed movement disorder

    • Cannot consent due to language or capacity

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Imperial College Healthcare NHS Trust London United Kingdom W2 1NY

    Sponsors and Collaborators

    • Imperial College London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT03635723
    Other Study ID Numbers:
    • 15/LO/1038 BRACELET
    First Posted:
    Aug 17, 2018
    Last Update Posted:
    Feb 17, 2020
    Last Verified:
    Feb 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Imperial College London
    Technology
    Rehabilitation
    Wearables
    Breast surgery
    Physical activity
    Enhanced recovery after surgery
    Additional relevant MeSH terms:
    Mobility Limitation

    Study Results

    No Results Posted as of Feb 17, 2020