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Completed

NCT Number: NCT04185181

Virtual Reality Versus Proprioceptive Neuromuscular Facilitation on Postmastectomy Lymphedema

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.

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Key information

Conditions

Postmastectomy Lymphedema Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

faculty of physical therapy, Cairo university

Giza, 11432, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality

Other

wii video game based exercise

Proprioceptive Neuromuscular facilitation

Other

PNF with breathing

complete decogestive therapy

Other

pneumatic compression, manual lymph drainage, skin care and home exercise program

Primary outcomes

  1. lymphedema volume

    Time frame: 4 weeks

    turncated cone formula using circumferential measurement of both upper limbs

  2. 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.

Sponsors and collaborators

Lead sponsor

doaa atef

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2019
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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