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

NCT ID: NCT05661123

Last Updated: 2023-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Lower Limb Lymphedema Fibrosis Cellulitis of Leg

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

will receive Complete decongestive therapy in combination with kinesio tape

Group Type EXPERIMENTAL

Complete decongestive therapy

Intervention Type 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.

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.

Group Type OTHER

Complete decongestive therapy

Intervention Type OTHER

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

Interventions

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Complete decongestive therapy

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eva Magdy Bottros Nakhla

Physical therapist and Certified lymphedema therapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Sahel teaching hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Eva Nakhla

Role: CONTACT

0201220264801

Other Identifiers

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Lymphedema,fibrosis

Identifier Type: -

Identifier Source: org_study_id

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