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Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises | Clinical Trials | Clareo Health

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Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

NCT03999177•NYU Langone Health

View on ClinicalTrials.gov

Summary

Correct performance of therapeutic lymphatic exercises has the potential to relieve lymphedema symptoms and optimize limb volume and lymph fluid level, in turn to improve breast cancer survivors' quality of life and reduce the risk of lymphedema. Kinect-TOLF (Kinect-Enhanced The-Optimal-Lymph-Flow Training System) is an innovative intelligent Kinect-enhanced training system to teach patients to perform the lymphatic exercises correctly. The Kinect-TOLF training system is not a medical device but a computer/mobile and motion-sensor program that helps patients to perform the lymphatic exercises correctly. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. The goal of the proposed project is to evaluate the usability and feasibility of Kinect-TOLF.

Eligibility

Age

21 - 90 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Women who have received surgical treatment for breast cancer (Stage I-III), including mastectomy, lumpectomy, sentinel lymph node biopsy (SLNB), SLNB plus lymph node dissection or axillary lymph nodes dissection
•Report any persistent or intermittent pain or lymphedema symptoms in the ipsilateral upper limb or body at least 8 weeks after surgery, that is, beyond the expected period of healing
•May or may not have had neoadjuvant therapy or adjuvant therapy of chemotherapy or radiation
•Have history or no history of lymphedema or have or not been treated for lymphedema;
•Able to speak and understand English since the proposed usability testing is designed to only test the English version of the intervention.
•Women willing to come to the NYU Perlmutter Cancer Center for the research visit.

Exclusion Criteria

•Women diagnosed with breast cancer but did not undergo surgical treatment as breast surgery and removal of lymph nodes are the major treatment-related risk factors for lymphedema;
•Known metastatic disease (Stage IV), recurrence of cancer, or lymphedema due to cancer recurrence, or other bulk disease in the thoracic or cervical regions;
•Women with renal or heart failure, cardiac pacemaker or defibrillator, artificial limbs, or pregnant women as accurate measurement of body mass index (BMI) may not be possible with an impedance device according to the manufactures.

Locations (1)

NYU Langone Health

New York, New York, United States

Key Dates

Start Date

June 1, 2019

Primary Completion Date

September 1, 2019

Completion Date

September 1, 2019

Last Updated

July 10, 2020

Enrollment

ACTUAL participants

Conditions

Breast CancerLymphedema

Interventions

Kinect-TOLF Training System

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Usability and Feasibility Testing on Kinect-Enhanced Training System for Lymphatic Exercises

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer