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

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ClinicalTrials.gov Identifier: NCT02958332
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Universidad de Burgos

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Lymphedema Breastcancer Other: video game program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: video game program
Participants will play video games during 30 min , all along 5 sessions.
Other: video game program
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.




Primary Outcome Measures :
  1. Change in Range motion [ Time Frame: Pre intervention and one week after having finished the program ]
  2. Change in strength [ Time Frame: Pre intervention and one week after having finished the program ]
  3. Change in Oxford Shoulder Scale [ Time Frame: Pre intervention and one week after having finished the program ]
  4. Change in Shoulder Pain and Disability Index [ Time Frame: Pre intervention and one week after having finished the program ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958332


Locations
Spain
Universidad de Burgos. Facultad de Ciencias de la Salud.
Burgos, Spain, 09001
Sponsors and Collaborators
Universidad de Burgos
Investigators
Principal Investigator: Montserrat Santamaría-Vázquez, PhD Universidad de Burgos

Responsible Party: Universidad de Burgos
ClinicalTrials.gov Identifier: NCT02958332     History of Changes
Other Study ID Numbers: CB-MSV-19-09-2016
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Universidad de Burgos:
video games

Additional relevant MeSH terms:
Lymphedema
Breast Neoplasms
Lymphatic Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases