Back to resultsEffect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
Primary Purpose
Lower Limb Lymphedema, Fibrosis, Cellulitis of Leg
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Complete decongestive therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lower Limb Lymphedema focused on measuring Lymphedema, complete decongestive therapy, kinesio tape
Eligibility Criteria
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.
Sites / Locations
- Al Sahel teaching hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.
will receive complete decongestive therapy for 6 successive weeks.
Arm Description
will receive Complete decongestive therapy in combination with kinesio tape
Complete Decongestive Therapy(traditional physical therapy) that includes: Education. Skin care . Pneumatic compression device . Manual lymph draining . Multilayer short stretch compression bandages. Exercises.
Outcomes
Primary Outcome Measures
To assess limb volume
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
To assess skin extensibility
using tonometer at the beginning of the study and at last session after 6 weeks
To evaluate ankle range of motion
using digital goniometer at the ankle joint to assess the dorsi flexion degree at the beginning of the study and at the last session
To evaluate patient quality of life
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05661123
Brief Title
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
Official Title
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Limb Lymphedema, Fibrosis, Cellulitis of Leg
Keywords
Lymphedema, complete decongestive therapy, kinesio tape
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.
Arm Type
Experimental
Arm Description
will receive Complete decongestive therapy in combination with kinesio tape
Arm Title
will receive complete decongestive therapy for 6 successive weeks.
Arm Type
Other
Arm Description
Complete Decongestive Therapy(traditional physical therapy) that includes:
Education.
Skin care .
Pneumatic compression device .
Manual lymph draining .
Multilayer short stretch compression bandages.
Exercises.
Intervention Type
Other
Intervention Name(s)
Complete decongestive therapy
Intervention Description
Education.
Skin care .
Pneumatic compression device .
Manual lymph draining .
Multilayer short stretch compression bandages.
Exercises.
Primary Outcome Measure Information:
Title
To assess limb volume
Description
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
Time Frame
6 weeks
Title
To assess skin extensibility
Description
using tonometer at the beginning of the study and at last session after 6 weeks
Time Frame
6 weeks
Title
To evaluate ankle range of motion
Description
using digital goniometer at the ankle joint to assess the dorsi flexion degree at the beginning of the study and at the last session
Time Frame
6 weeks
Title
To evaluate patient quality of life
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Nakhla
Phone
0201220264801
Email
dr-evamagdy@hotmail.comm
Facility Information:
Facility Name
Al Sahel teaching hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis
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