Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
August 28, 2023 updated by: Eva Magdy Bottros Nakhla, Cairo University
this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with lower limbs fibrosis post cellulitis ,as well as finding out a physical therapy approach that has positive effect in treatment and care such cases which would enhance the physical therapy field.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Lymphedema patient need a rehabilitative intervention in two phases : decongestion phase to reduce edema volume , improve the skin extensibility and provide him a better quality of life, followed by the maintenance phase to keep the outcomes.
When we use the kinesio tape in addition to the complete decongestive therapy, the patient will experience a better improvement in the edema volume and the skin extensibility within a shorter period of time , a lesser number of sessions and a lower cost.
So, the patient will have a better quality of life and could be a productive person in the society.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eva Nakhla
- Phone Number: 0201220264801
- Email: dr-evamagdy@hotmail.comm
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Al Sahel teaching hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years to 51 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
The patient will be according the following criteria:-
- Males and females with Lower limb lymphedema Stage 2.
- Age will range from45 to 55years old.
- BMI <40 (kg/m2).
- All patients will be clinically and medically stable when attending the study.
- Patients free from any acute conditions.
- Post cellulitis for at least 2 weeks.
Exclusion Criteria:
- Unstable cardiovascular problems.
- Altered mental status or poor cognition.
- Lower limb ischemia (ABI ≤0.8).
- Lower limb lymphedema stage 3&4.
- Acute deep venous thrombosis.
- Any acute infection.
- Patients with orthopedic or neurological limitations to exercise.
- Any lower limb acute ulcer or arterial wounds.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.
will receive Complete decongestive therapy in combination with kinesio tape
|
|
|
Other: will receive complete decongestive therapy for 6 successive weeks.
Complete Decongestive Therapy(traditional physical therapy) that includes:
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To assess limb volume
Time Frame: 6 weeks
|
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
|
6 weeks
|
|
To assess skin extensibility
Time Frame: 6 weeks
|
using tonometer at the beginning of the study and at last session after 6 weeks
|
6 weeks
|
|
To evaluate ankle range of motion
Time Frame: 6 weeks
|
using digital goniometer at the ankle joint to assess the dorsi flexion degree at the beginning of the study and at the last session
|
6 weeks
|
|
To evaluate patient quality of life
Time Frame: 6 weeks
|
using Lymphedema life impact scale in form of 18 questions every question' answer from 0 ( no symptoms) to 4 ( sever symptoms) at the beginning of the study and at the end of sessions
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 20, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
June 1, 2024
Study Registration Dates
First Submitted
November 27, 2022
First Submitted That Met QC Criteria
December 13, 2022
First Posted (Actual)
December 22, 2022
Study Record Updates
Last Update Posted (Actual)
August 30, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Lymphedema,fibrosis
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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