The Validity and Reliability of Self Measurement of Upper Limb Volume
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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 |
- 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) |
-
Other: Self measurement of limb volume +water displacement
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders 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
Contacts and Locations| Contact: Tali Mori, BPT | 0528715709 | mnoa@bezeqint.net |
| Israel | |
| Remez Health center | Recruiting |
| Rechovot, Israel | |
| Contact: Tali Mori 0528715709 | |
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 June 18, 2013