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The Validity and Reliability of Self Measurement of Upper Limb Volume

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ClinicalTrials.gov Identifier: NCT01225783
Recruitment Status : Unknown
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : October 21, 2010
Last Update Posted : March 19, 2012
Information provided by (Responsible Party):
Meir Medical Center

Brief Summary:
Lymphedema is a common, chronic, side effect resulting from the treatment of breast cancer.Insufficiency in the lymphatic system causes edema in the upper limb. The accepted conservative treatment is based on the anatomy and physiology of the lymphatic system. The aim of the treatment is to reduce the volume of the upper limb by, initial, intensive treatment and then to keep the arm volume at this reduced level.The measurement of limb volume involves measuring the circumference of the arm at defined points and then with the use of a formula the volume of the arm can be calculated. After intensive therapy is complete the responsibility for measuring limb volume moves to the patient. This study will examine the reliability and validity of self measurement of limb volume. The investigators will compare the results of self measurement using the accepted plastic tapemeasure against a paper tape measure adapted for self measurement.Both methods will be compared to the "gold standard volume displacement. In the study there will be two meetings with the subjects where the patient and physiotherapist will use the three methods.

Condition or disease Intervention/treatment
Limb Volume Measurement Other: Self measurement of limb volume +water displacement

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Validity and Reliability of Self Measurement of Upper Limb Volume in Treating Lymphedema in Breast Cancer Patients
Study Start Date : November 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Other: Self measurement of limb volume +water displacement
    Comparison will be made between self measurement is two types of tape measure compared with water displacement

Primary Outcome Measures :
  1. Comparison of self measurement of limb volume to water displacement [ Time Frame: 2 years ]
  2. validity of self measurement [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women with arm edema after breast cancer who are being conservatively treated by a physiotherapist.

Exclusion Criteria:

  • Active malignant disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225783

Contact: Tali Mori, BPT 0528715709 mnoa@bezeqint.net

Remez Health center Recruiting
Rechovot, Israel
Contact: Tali Mori    0528715709      
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01225783     History of Changes
Other Study ID Numbers: MMC10095KCTIL
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012