Postmastectomy LymphedemaNCT04185181
Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
A study testing virtual reality, proprioceptive neuromuscular facilitation and complete decogestive therapy in people with Postmastectomy Lymphedema, run by doaa atef at 1 site in Egypt.
Trial summary
This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into two equal groups, 15 in each. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Postmastectomy Lymphedema
- What is being tested?
- virtual reality, proprioceptive neuromuscular facilitation and complete decogestive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2018to 31 Aug 2019
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will suffer from unilateral post-mastectomy lymphedema.
- Stage I and stage II lymphedema as defined by the classification of the International Society of Lymphology (The International Society of Lymphology, 2003).
- Patients had no physical therapy before the current treatment or the last time to receive sessions was at least three months ago.
Who cannot join
- Excluded patients were having musculoskeletal or neurological disorders that would impair performance during training and tests.
- Visual disorders that could affect imitation of video game-based exercise.
- Uncontrolled cardiovascular or pulmonary diseases.
- Psychiatric illness, severe behavior, and cognitive disorders.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into two equal groups, 15 in each. Fifteen patients performed virtual reality-based exercises plus complete decongestive therapy, while the other fifteen patients performed proprioceptive neuromuscular facilitation plus complete decongestive therapy. The volume difference between normal and affected limbs was calculated before and after eight sessions of treatment for both groups by using the circumferential method. And the upper limb function was assessed before and after eight sessions of treatment for both groups by using the Arabic version of the Quick DASH scale.
- Conditions
- Postmastectomy Lymphedema
- Being tested
- virtual reality, proprioceptive neuromuscular facilitation, complete decogestive therapy
- 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.
virtual realityOther
wii video game based exercise
proprioceptive neuromuscular facilitationOther
PNF with breathing
complete decogestive therapyOther
pneumatic compression, manual lymph drainage, skin care and home exercise program
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Active comparator | Not described Receives: Other: virtual reality; Other: complete decogestive therapy |
| propreoceptive neuromuscular facilitation | Active comparator | Not described Receives: Other: proprioceptive neuromuscular facilitation; Other: complete decogestive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
lymphedema volume
turncated cone formula using circumferential measurement of both upper limbs
Measured: 4 weeks
upper limb function
quick-disability of arm, shoulder and hand (DASH) scale. minimum score is zero and maximum score is 44. higher score means worse outcome.
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 posted4 Dec 2019
- Study start30 Jun 2018
- Primary completion5 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmastectomy 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- doaa atef
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, doaa atef, Cairo University
- Investigators
- doaa AA abd-el-wahed, A.lecturer, Principal investigator, assistant lecturer at faculty of physical therapy, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185181
- Sponsor's protocol ID
- Doaa Atef
- Status last verified
- Dec 2019
- First submitted
- 26 Nov 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atef D, Elkeblawy MM, El-Sebaie A, Abouelnaga WAI. A quasi-randomized clinical trial: virtual reality versus proprioceptive neuromuscular facilitation for postmastectomy lymphedema. J Egypt Natl Canc Inst. 2020 Jun 15;32(1):29. doi: 10.1186/s43046-020-00041-5.
PubMed 32537717
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema
- ClinicalTrials.gov ID
- NCT04185181
- Acronym / sponsor ID
- Doaa Atef
- Conditions
- Postmastectomy Lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- doaa atefUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 4 Dec 2019 (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.
This study aimed to compare the therapeutic efficacy of VR and PNF on lymphedema and function in unilateral post-mastectomy lymphedema (UPML) patients. The patients were subdivided into two equal groups, 15 in each. Fifteen patients performed virtual reality-based exercises plus complete decongestive therapy, while the other fifteen patients performed proprioceptive neuromuscular facilitation plus complete decongestive therapy. The volume difference between normal and affected limbs was calculated before and after eight sessions of treatment for both groups by using the circumferential method. And the upper limb function was assessed before and after eight sessions of treatment for both groups by using the Arabic version of the Quick DASH scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Active comparator | Other: virtual reality, Other: complete decogestive therapy |
| propreoceptive neuromuscular facilitation | Active comparator | Other: proprioceptive neuromuscular facilitation, Other: complete decogestive therapy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will suffer from unilateral post-mastectomy lymphedema.
- Stage I and stage II lymphedema as defined by the classification of the International Society of Lymphology (The International Society of Lymphology, 2003).
- Patients had no physical therapy before the current treatment or the last time to receive sessions was at least three months ago.
Key exclusion criteria (4 listed)
- Excluded patients were having musculoskeletal or neurological disorders that would impair performance during training and tests.
- Visual disorders that could affect imitation of video game-based exercise.
- Uncontrolled cardiovascular or pulmonary diseases.
- Psychiatric illness, severe behavior, and cognitive disorders.
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 |
|---|---|---|
| virtual realitywii video game based exercise | Other | virtual reality |
| proprioceptive neuromuscular facilitationPNF with breathing | Other | propreoceptive neuromuscular facilitation |
| complete decogestive therapypneumatic compression, manual lymph drainage, skin care and home exercise program | Other | propreoceptive neuromuscular facilitation, virtual reality |
Primary outcome
lymphedema volume
Time frame: 4 weeks
turncated cone formula using circumferential measurement of both upper limbs
upper limb function
Time frame: 4 weeks
quick-disability of arm, shoulder and hand (DASH) scale. minimum score is zero and maximum score is 44. higher score means worse outcome.
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 5 Dec 2019.
- Derived from this study: PubMed 32537717Atef D, Elkeblawy MM, El-Sebaie A, Abouelnaga WAI. A quasi-randomized clinical trial: virtual reality versus proprioceptive neuromuscular facilitation for postmastectomy lymphedema. J Egypt Natl Canc Inst. 2020 Jun 15;32(1):29. doi: 10.1186/s43046-020-00041-5.
- 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 AA abd-el-wahed, A.lecturer principal investigator
assistant lecturer at faculty of physical therapy, 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 virtual reality, proprioceptive neuromuscular facilitation and complete decogestive therapy in people with Postmastectomy Lymphedema, run by doaa atef 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: finished, as of the sponsor's last update on 5 Dec 2019. 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?
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?
lymphedema volume (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185181, which also lists 1 linked publication.
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 5 Dec 2019.