An interventional study of Complete decongestive therapy in Lower Limb Lymphedema, Fibrosis and Cellulitis of Leg, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 45 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Lymphedema, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Fibrosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patient will be according the following criteria:-
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
will receive Complete decongestive therapy in combination with kinesio tape
Other: 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.
Other: Complete decongestive therapy
1. Education. 2. Skin care . 3. Pneumatic compression device . 4. Manual lymph draining . 5. Multilayer short stretch compression bandages. 6. Exercises.
To assess limb volume
using Circumferential tape measurement to measure round measurements in cm at the beginning of the study then every 3 sessions
Time frame: 6 weeks
To assess skin extensibility
using tonometer at the beginning of the study and at last session after 6 weeks
Time frame: 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
Time frame: 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
Time frame: 6 weeks
Start is estimated for Sep 2023; primary completion for Mar 2024, 6 months later.
Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 6 months is below that.
Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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