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

NCT05661123 | Unknown DMC

• 1 other identifier: Lymphedema,fibrosis
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Lymphedema; Fibrosis; Cellulitis of Leg

Keywords

Lymphedema; complete decongestive therapy; kinesio tape

Outcome Measures

Primary Outcomes (4)

• To assess limb volume

  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

  using tonometer at the beginning of the study and at last session after 6 weeks

  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

  6 weeks

• 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

  6 weeks

Study Arms (2)

will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.

EXPERIMENTAL

will receive Complete decongestive therapy in combination with kinesio tape

Other: Complete decongestive therapy

will receive complete decongestive therapy for 6 successive weeks.

OTHER

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.

Other: Complete decongestive therapy

Interventions

Complete decongestive therapy OTHER

1. Education. 2. Skin care . 3. Pneumatic compression device . 4. Manual lymph draining . 5. Multilayer short stretch compression bandages. 6. Exercises.

will receive complete decongestive therapy for 6 successive weeks.; will receive kinesio tape in addition to complete decongestive therapy for 6 successive weeks.

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Al Sahel teaching hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Fibrosis; Lymphedema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Eva Nakhla

CONTACT

0201220264801; dr-evamagdy@hotmail.comm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist and Certified lymphedema therapist

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 22, 2022
• Study Start: September 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

EG (1)