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

Primary Purpose

Lymphedema, Breastcancer

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

video game program

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring video games

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidad de Burgos. Facultad de Ciencias de la Salud.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

video game program

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Range motion

Change in strength

Change in Oxford Shoulder Scale

Change in Shoulder Pain and Disability Index

Secondary Outcome Measures

Change in quality of life (FUNCTIONAL ASSESMENT OF CANCER THERAPY QUESTIONNAIRE FOR BREAST CANCER (FACT-B+4)

Full Information

NCT ID

NCT02958332

First Posted

October 28, 2016

Last Updated

May 3, 2017

Sponsor

Universidad de Burgos

1. Study Identification

Unique Protocol Identification Number

NCT02958332

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad de Burgos

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphedema, Breastcancer

Keywords

video games

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

video game program

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

video game program

Intervention Description

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 Outcome Measure Information:

Title

Change in Range motion

Time Frame