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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958332
• Other study ID #: CB-MSV-19-09-2016
• Status: Completed
• Phase: N/A
• First received: October 28, 2016
• Last updated: May 3, 2017
• Start date: November 2016
• Est. completion date: January 2017

Study information

• Verified date: May 2017
• Source: Universidad de Burgos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Breastcancer
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Burgos. Facultad de Ciencias de la Salud.	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Burgos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Range motion		Pre intervention and one week after having finished the program
Primary	Change in strength		Pre intervention and one week after having finished the program
Primary	Change in Oxford Shoulder Scale		Pre intervention and one week after having finished the program
Primary	Change in Shoulder Pain and Disability Index		Pre intervention and one week after having finished the program
Secondary	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