The Validity and Reliability of Self Measurement of Upper Limb Volume

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01225783
First received: October 20, 2010
Last updated: March 16, 2012
Last verified: March 2012
  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: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • validity of self measurement [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01225783     History of Changes
Other Study ID Numbers: MMC10095KCTIL
Study First Received: October 20, 2010
Last Updated: March 16, 2012
Health Authority: Israel:Clalit Health Services

ClinicalTrials.gov processed this record on April 16, 2014