The Validity and Reliability of Self Measurement of Upper Limb Volume

Limb Volume Measurement Clinical Trial

Official title:

The Validity and Reliability of Self Measurement of Upper Limb Volume in Treating Lymphedema in Breast Cancer Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01225783
• Other study ID #: MMC10095KCTIL
• Status: Unknown status
• Phase: N/A
• First received: October 20, 2010
• Last updated: March 16, 2012
• Start date: November 2010
• Est. completion date: October 2012

Study information

• Verified date: March 2012
• Source: Meir Medical Center
• Contact: Tali Mori, BPT
• Phone: 0528715709
• Email: mnoa[@]bezeqint.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Active malignant disease

Related Conditions & MeSH terms

• Limb Volume Measurement

Intervention

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

Locations

Country	Name	City	State
Israel	Remez Health center	Rechovot

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of self measurement of limb volume to water displacement		2 years
Primary	validity of self measurement		2 years