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The Validity and Reliability of Self Measurement of Upper Limb Volume

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Meir Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01225783
First Posted: October 21, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose
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 Intervention
Limb Volume Measurement Other: Self measurement of limb volume +water displacement

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

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

Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Active malignant disease
  Contacts and Locations
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


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

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

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01225783     History of Changes
Other Study ID Numbers: MMC10095KCTIL
First Submitted: October 20, 2010
First Posted: October 21, 2010
Last Update Posted: October 12, 2017
Last Verified: March 2012