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

NYU Langone Health

Status

Completed

Conditions

Breast Cancer

Lymphedema

Treatments

Behavioral: Kinect-TOLF Training System

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03999177

19-00222

1R01CA214085 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

21 to 90 years old

Volunteers

No 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.