Postmastectomy LymphedemaNCT05726656
Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy Lymphedema Patients
A study testing traditional physical therapy session and wii console based exercise in people with Postmastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Postmastectomy Lymphedema
- What is being tested?
- traditional physical therapy session and wii console based exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to Dec 2023
- 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 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All the patients will be females.
- Patients undergone mastectomy with lymph nodes dissection.
- all developed lymphedema after the surgery.
Who cannot join
- Vision problems.
- Medically instable patients.
- Balance disorders.
- Other musculoskeletal condition of shoulders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy
Giza, 11432
Doaa A Atef, PHD, 01060267094 ext. 002, doozy.masr@gmail.com
Ayah M Mohamed, PHD
About this study
Official title: Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy
PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.
Read the detailed description
Breast cancer has been the focused of many studies because it significantly affects both in developed and developing countries worldwide (Cameirão et al, 2008).
Lymphedema affects the range of motion of shoulder causing disability and affection of function.
Wii-console systems can be used as training tools to promote intensive training directed towards specific deficits and guide the patients in task-oriented activities. Moreover, it allows a real-time high-resolution monitoring, where is possible to have a quantitative assessment of relevant properties of the impairment, performance and recovery. On the other hand, virtual reality environment demand focus and attention of the patient, motivate the patient to perform the exercises, and provide a sense of achievement to the user (Torre et al, 2015).
HYPOTHESES:
The wii-console based exercise will have no effect on shoulder ROM for post-mastectomy patients.
- Conditions
- Postmastectomy Lymphedema
- Being tested
- traditional physical therapy session, wii console based exercise
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional physical therapy sessionOther
manual lymph drainage-pneumatic compression and skin care
wii console based exerciseOther
execise session using the wii console video games
| Study group | Role | What they receive |
|---|---|---|
| wii console based exercise group | Experimental | the patient will recieve wii console based exercise in addition to traditional physical therapy session Receives: Other: traditional physical therapy session; Other: wii console based exercise |
| control group | Other | the patient will recieve only the traditional physical therapy session Receives: Other: traditional physical therapy session |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder range of motion
flexion, extension, abduction, adduction , internal rotation and external rotation
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmastectomy LymphedemaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa atef, Cairo University
- Investigators
- Doaa A Atef, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726656
- Sponsor's protocol ID
- P.T.REC/012/004199
- Status last verified
- Sep 2023
- First submitted
- 3 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wii-console Based Exercise on Shoulder Range of Motion for Post-mastectomy
- ClinicalTrials.gov ID
- NCT05726656
- Acronym / sponsor ID
- P.T.REC/012/004199
- Conditions
- Postmastectomy Lymphedema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- 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.
PURPOSE: To determine the effect of wii-console based exercise on shoulder ROM of both sides for post-mastectomy patients, and highlighting the effect of dominancy.
Detailed description
Breast cancer has been the focused of many studies because it significantly affects both in developed and developing countries worldwide (Cameirão et al, 2008).
Lymphedema affects the range of motion of shoulder causing disability and affection of function.
Wii-console systems can be used as training tools to promote intensive training directed towards specific deficits and guide the patients in task-oriented activities. Moreover, it allows a real-time high-resolution monitoring, where is possible to have a quantitative assessment of relevant properties of the impairment, performance and recovery. On the other hand, virtual reality environment demand focus and attention of the patient, motivate the patient to perform the exercises, and provide a sense of achievement to the user (Torre et al, 2015).
HYPOTHESES:
The wii-console based exercise will have no effect on shoulder ROM for post-mastectomy patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wii console based exercise group | Experimental | Other: traditional physical therapy session, Other: wii console based exercisethe patient will recieve wii console based exercise in addition to traditional physical therapy session |
| control group | Other | Other: traditional physical therapy sessionthe patient will recieve only the traditional physical therapy session |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All the patients will be females.
- Patients undergone mastectomy with lymph nodes dissection.
- all developed lymphedema after the surgery.
Key exclusion criteria (4 listed)
- Vision problems.
- Medically instable patients.
- Balance disorders.
- Other musculoskeletal condition of shoulders.
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 |
|---|---|---|
| traditional physical therapy sessionmanual lymph drainage-pneumatic compression and skin care | Other | control group, wii console based exercise group |
| wii console based exerciseexecise session using the wii console video games | Other | wii console based exercise group |
Primary outcome
shoulder range of motion
Time frame: 4 weeks
flexion, extension, abduction, adduction , internal rotation and external rotation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Doaa A Atef, PHD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing traditional physical therapy session and wii console based exercise in people with Postmastectomy Lymphedema, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa A Atef, PHD (01060267094 ext. 002, doozy.masr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder range of motion (time frame: 4 weeks). 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 21 Sep 2023.