Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer

May 3, 2017 updated by: Universidad de Burgos

Aims: To demonstrate the effect of a program based on video games as a means to improve abilities and basic skills affected by lymphedema, and its impact on quality of life.

Design: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor blinded study.

Method: Data on shoulder pain and disability, health-related quality of life, strength and articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer), respectively goniometry and dynamometry amplitude scales will be collected.

The intervention will be performed with the Wii ™ console and the Wii Balance BoardTM, during 5 individual weekly sessions of 30 minutes.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Burgos, Spain, 09001
        • Universidad de Burgos. Facultad de Ciencias de la Salud.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be over 18 years
  • Have a diagnosis of lymphedema, secondary to breast cancer

Exclusion Criteria:

  • Stage 0 or subclinical lymphedema
  • Present other shoulder pathology apart from lymphedema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video game program
Participants will play video games during 30 min , all along 5 sessions.
Participants will use the Wii console and the Wii balance board, to play different video games which imply shoulder movements. They will receive 5 individual sessions of 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Range motion
Time Frame: Pre intervention and one week after having finished the program
Pre intervention and one week after having finished the program
Change in strength
Time Frame: Pre intervention and one week after having finished the program
Pre intervention and one week after having finished the program
Change in Oxford Shoulder Scale
Time Frame: Pre intervention and one week after having finished the program
Pre intervention and one week after having finished the program
Change in Shoulder Pain and Disability Index
Time Frame: Pre intervention and one week after having finished the program
Pre intervention and one week after having finished the program

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in quality of life (FUNCTIONAL ASSESMENT OF CANCER THERAPY QUESTIONNAIRE FOR BREAST CANCER (FACT-B+4)
Time Frame: Pre intervention and one week after having finished the program
Pre intervention and one week after having finished the program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Montserrat Santamaría-Vázquez, PhD, Universidad de Burgos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CB-MSV-19-09-2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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