- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Burgos, Spain, 09001
- Universidad de Burgos. Facultad de Ciencias de la Salud.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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Experimental: video game program
Participants will play video games during 30 min , all along 5 sessions.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Range motion
Time Frame: Pre intervention and one week after having finished the program
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Pre intervention and one week after having finished the program
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Change in strength
Time Frame: Pre intervention and one week after having finished the program
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Pre intervention and one week after having finished the program
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Change in Oxford Shoulder Scale
Time Frame: Pre intervention and one week after having finished the program
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Pre intervention and one week after having finished the program
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Change in Shoulder Pain and Disability Index
Time Frame: Pre intervention and one week after having finished the program
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Pre intervention and one week after having finished the program
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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
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Pre intervention and one week after having finished the program
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Montserrat Santamaría-Vázquez, PhD, Universidad de Burgos
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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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