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Completed

NCT Number: NCT02958332

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

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.

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Key information

Conditions

Lymphedema Breastcancer Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Burgos. Facultad de Ciencias de la Salud.

Burgos, 09001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video game program

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Burgos

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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