CClinicalTrials.gg
CompletedNCT02958332Updated May 4, 2017

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

An interventional study of video game program in Lymphedema and Breastcancer, sponsored by Universidad de Burgos. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by Universidad de Burgos · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lymphedema
  • Breastcancer

Keywords

  • video games
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 11 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Universidad de Burgos is the lead sponsor of 24 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Stage 0 or subclinical lymphedema
  • Present other shoulder pathology apart from lymphedema
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    video game program

    Participants will play video games during 30 min , all along 5 sessions.

    Other: video game program

Interventions

  • Othervideo 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.

06

What researchers measure

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

07

Study locations

1 site
  • Universidad de Burgos. Facultad de Ciencias de la Salud.
    Burgos, 09001, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02958332
Lead sponsor
Universidad de Burgos
Responsible party
Sponsor
First posted
Nov 8, 2016
Start date
Nov 2016
Primary completion
Dec 2016
Completion
Jan 2017
Last update
May 4, 2017

Study contacts

Montserrat Santamaría-Vázquez, PhD
principal investigator · Universidad de Burgos

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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