Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema

December 3, 2019 updated by: doaa atef
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Giza, Egypt, 11432
        • Faculty of physical therapy, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: virtual reality
Other: virtual reality
wii video game based exercise
Other: complete decogestive therapy
pneumatic compression, manual lymph drainage, skin care and home exercise program
ACTIVE_COMPARATOR: propreoceptive neuromuscular facilitation
Other: complete decogestive therapy
pneumatic compression, manual lymph drainage, skin care and home exercise program
Other: proprioceptive neuromuscular facilitation
PNF with breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lymphedema volume
Time Frame: 4 weeks
turncated cone formula using circumferential measurement of both upper limbs
4 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

doaa atef

Investigators

  • Principal Investigator: doaa AA abd-el-wahed, A.lecturer, assistant lecturer at faculty of physical therapy, Cairo university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 30, 2018

Primary Completion (ACTUAL)

August 5, 2019

Study Completion (ACTUAL)

August 31, 2019

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

December 1, 2019

First Posted (ACTUAL)

December 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Doaa Atef

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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