The Validity and Reliability of Self Measurement of Upper Limb Volume

NCT ID: NCT01225783

Last Updated: 2012-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-10-31

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.

Conditions

Limb Volume Measurement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Self measurement of limb volume +water displacement

Comparison will be made between self measurement is two types of tape measure compared with water displacement

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Active malignant disease

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Remez Health center

Rehovot, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Tali Mori, BPT

Role: CONTACT

mnoa@bezeqint.net

0528715709

Facility Contacts

Tali Mori

Role: primary

0528715709

Other Identifiers

MMC10095KCTIL

Identifier Type: -

Identifier Source: org_study_id