LymphedemaNCT02958332
Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
A study testing video game program in people with Lymphedema and Breastcancer, run by Universidad de Burgos at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema, Breastcancer
- What is being tested?
- video game program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be over 18 years
- Have a diagnosis of lymphedema, secondary to breast cancer
Who cannot join
- Stage 0 or subclinical lymphedema
- Present other shoulder pathology apart from lymphedema
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Burgos. Facultad de Ciencias de la Salud.
Burgos, 09001
About this study
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.
Read more
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.
- Conditions
- Lymphedema, Breastcancer
- Being tested
- video game program
- Keywords
- video games
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video game programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| video game program | Experimental | Participants will play video games during 30 min , all along 5 sessions. Receives: Other: video game program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Range motion
Measured: Pre intervention and one week after having finished the program
Change in strength
Measured: Pre intervention and one week after having finished the program
Change in Oxford Shoulder Scale
Measured: Pre intervention and one week after having finished the program
Change in Shoulder Pain and Disability Index
Measured: 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)
Measured: Pre intervention and one week after having finished the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montserrat Santamaría-Vázquez, PhD, Principal investigator, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958332
- Sponsor's protocol ID
- CB-MSV-19-09-2016
- Status last verified
- May 2017
- First submitted
- 28 Oct 2016
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
- ClinicalTrials.gov ID
- NCT02958332
- Acronym / sponsor ID
- CB-MSV-19-09-2016
- Conditions
- Lymphedema, Breastcancer
- Keywords
- video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video game program | Experimental | Other: video game programParticipants will play video games during 30 min , all along 5 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be over 18 years
- Have a diagnosis of lymphedema, secondary to breast cancer
Key exclusion criteria (2 listed)
- Stage 0 or subclinical lymphedema
- Present other shoulder pathology apart from lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| video game programParticipants 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. | Other | video game program |
Primary outcome
Change in Range motion
Time frame: Pre intervention and one week after having finished the program
Change in strength
Time frame: Pre intervention and one week after having finished the program
Change in Oxford Shoulder Scale
Time frame: Pre intervention and one week after having finished the program
Change in Shoulder Pain and Disability Index
Time frame: Pre intervention and one week after having finished the program
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Santamaría-Vázquez, PhD principal investigator
Universidad de Burgos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing video game program in people with Lymphedema and Breastcancer, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Range motion (time frame: Pre intervention and one week after having finished the program). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.