Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 4, 2017
May 1, 2017
1 month
October 28, 2016
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Range motion
Pre intervention and one week after having finished the program
Change in strength
Pre intervention and one week after having finished the program
Change in Oxford Shoulder Scale
Pre intervention and one week after having finished the program
Change in Shoulder Pain and Disability Index
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)
Pre intervention and one week after having finished the program
Study Arms (1)
video game program
EXPERIMENTALParticipants will play video games during 30 min , all along 5 sessions.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Be over 18 years
- Have a diagnosis of lymphedema, secondary to breast cancer
You may not qualify if:
- Stage 0 or subclinical lymphedema
- Present other shoulder pathology apart from lymphedema
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad de Burgos. Facultad de Ciencias de la Salud.
Burgos, 09001, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Montserrat Santamaría-Vázquez, PhD
Universidad de Burgos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 8, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
May 4, 2017
Record last verified: 2017-05