NCT00155220

Brief Summary

There are 2 parts to this study. First part:

  • Reliability of water displacement, circumference, tonometer.
  • Effect of taping: lifting effect measured with sonography
  • Effect of taping: peripheral circulation measured with DRT4 Second part:
  • Effects of different intervention models including decongestive lymphatic therapy (DLT) and modified DLT

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 27, 2006

Status Verified

August 1, 2004

First QC Date

September 8, 2005

Last Update Submit

January 25, 2006

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (2)

  • The severity of swelling, such as arm circumference, volume of water displacement

  • The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention.

Secondary Outcomes (2)

  • Related symptoms, the upper extremity function and quality of life

  • The evaluation time the same as primary outcomes

Interventions

Low Stretch Bandage and Kinesio TapeDEVICE

Eligibility Criteria

Age30 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female breast cancer lymphedema
  • Unilateral lymphedema
  • Lymphedema onset 3 months ago
  • Moderate to severe lymphedema
  • At least one measurement point greater than 2 cm
  • Good compliance

You may not qualify if:

  • Port-a-cath on affected side of chest with adhesion
  • Skin disease
  • Restriction of active range of motion
  • Affected upper extremity (UE)
  • Other diseases or medication might lead to swelling
  • Irremovable bracelet or ring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphedema

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Jau-Yih Tsauo, PhD

    NTUH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Study Completion

March 1, 2006

Last Updated

January 27, 2006

Record last verified: 2004-08

Locations

TW(1)