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Clinical Trials/NCT05661123
NCT05661123RecruitingNot Applicable

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

Cairo University1 site in 1 country30 target enrollmentStarted: September 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
1
Primary Endpoint
To evaluate patient quality of life

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
45 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The patient will be according the following criteria:-
  • •Males and females with Lower limb lymphedema Stage
  • •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&
  • •Acute deep venous thrombosis.
  • •Any acute infection.
  • •Patients with orthopedic or neurological limitations to exercise.
  • •Any lower limb acute ulcer or arterial wounds.

Arms & Interventions

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

Intervention: Complete decongestive therapy (Other)

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.

Intervention: Complete decongestive therapy (Other)

Outcomes

Primary Outcomes

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

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

To assess skin extensibility

Time Frame: 6 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eva Magdy Bottros Nakhla

Physical therapist and Certified lymphedema therapist

Cairo University

Study Sites (1)

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