Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis

Not Applicable

Recruiting

• Conditions: Cellulitis of Leg; Fibrosis; Lower Limb Lymphedema
• Interventions: Other: Complete decongestive therapy

• Registration Number: NCT05661123
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Study Start: 2023-09-20
• Primary Completion: 2024-03
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

The patient will be according the following criteria:-

1. Males and females with Lower limb lymphedema Stage 2.
2. Age will range from45 to 55years old.
3. BMI <40 (kg/m2).
4. All patients will be clinically and medically stable when attending the study.
5. Patients free from any acute conditions.
6. Post cellulitis for at least 2 weeks.

Exclusion Criteria

1. Unstable cardiovascular problems.
2. Altered mental status or poor cognition.
3. Lower limb ischemia (ABI ≤0.8).
4. Lower limb lymphedema stage 3&4.
5. Acute deep venous thrombosis.
6. Any acute infection.
7. Patients with orthopedic or neurological limitations to exercise.
8. Any lower limb acute ulcer or arterial wounds.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.	Complete decongestive therapy	will receive Complete decongestive therapy in combination with kinesio tape
will receive complete decongestive therapy for 6 successive weeks.	Complete decongestive therapy	Complete Decongestive Therapy(traditional physical therapy) that includes: 1. Education. 2. Skin care . 3. Pneumatic compression device . 4. Manual lymph draining . 5. Multilayer short stretch compression bandages. 6. Exercises.

Primary Outcome Measures

Name	Time	Method
To evaluate patient quality of life	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
To assess limb volume	6 weeks	using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
To assess skin extensibility	6 weeks	using tonometer at the beginning of the study and at last session after 6 weeks
To evaluate ankle range of motion	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

Trial Locations

Locations (1)

Al Sahel teaching hospital; 🇪🇬 Cairo, Egypt