The Effect of Dynamic Neuromuscular Stabilization Exercises in Patients With Lower Extremity Lymphedema
NCT Number: NCT06545383
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Lymphedema, Lower Limb
Interventions: OTHER: Dynamic Neuromuscular Stabilization Exercises|OTHER: Exercise
Sponsor: Istanbul University - Cerrahpasa (IUC)
Collaborators: Bezmialem Vakif University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 42
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-02-01
Locations: Istanbul University-Cerrahpasa, Istanbul, Büyükçekmece, Turkey|Bezmialem Vakif University, Istanbul, Fatih, Turkey

Summary:
After lower extremity lymphedema, individuals physical activity levels and functionality remain very low. This decrease can cause balance problems over time. Surgical and medical treatments reduce the nerve conduction efficiency of the nervous system and negatively affect proprioception, which is the perception of the joint's position in space during movement. Increasing errors in joint position sense reduce control of movement and restrict active movement, which lead to an assumption that balance could be affected. Joint position sense and balance may be negatively affected, causing injuries, and injuries may cause damage to ligaments and sensory nerve fibers. The main aim of the Dynamic Neuromuscular Stabilization (DNS) approach is to restore physiological movement patterns. By activating the deep stabilizer system with DNS exercises, joint movements could improved, and exercise positions will have positive effects on the quality of sensory perception. In addition, positive effects on balance are expected due to decrease in joint position sense errors. Therefore, the aim of the study is to investigate/understand the effect of DNS exercises on balance, proprioception and functional level in patients with lower extremity lymphedema. This study will provide information for researchers, therapists, and patients by determining the effectiveness of DNS exercises in patients with lower extremity lymphedema.

from Bezmiâlem Vakıf University Faculty of Medicine, Department of Physical Therapy and Rehabilitation, who have been diagnosed with lymphedema due to primary or secondary causes and have progressed to the Complex Decongestive Treatment Phase 2, will constitute the population of the study. The study will be carried out at Istanbul University-Cerrahpaşa Department of Physiotherapy and Rehabilitation.

The study will consist of two groups. Both groups will be included in an exercise program consisting of breathing exercises, active joint range of motion exercises and walking training. Exercises will be given as a home program for 6 weeks, 3 days a week, 45 minutes a day. Additionally, patients in the Control group will be asked to walk for 40 minutes 2 days a week for 6 weeks. In the intervention group, they will additionally be included in a program consisting of individualized DNS exercises for 40 minutes a day, 2 days a week for 6 weeks. All patients will be asked to wear compression garments during exercises.

Primary Outcome Measures: Change from Baseline in Static Balance on the One-Leg Stance Test, With this test, static balance is evaluated. It correlates well with other balance tests. It is time efficient and does not require the use of special equipment. The test is performed without shoes on a smooth and hard surface. It is measured how long the individual can stand on one leg without assistance, with the arms close to the body. The time is recorded with chronometer. The duration starts when the patient lifts his foot off the ground and ends when his foot touches the ground. The test ends when the foot is moved or the time reaches a maximum of 60 seconds. The average of 3 repetitions is taken. The time is recorded in seconds. Standing on one leg for longer periods of time indicates better balance. The test will be applied with eyes open and closed., Six week|Change from Baseline in Dynamic Balance on the Y Balance Test, The Y balance test evaluates the dynamic balance of the lower extremity. Three lines in the shape of a "Y" are drawn in the test area, with a 135-degree angle between the back strips and the front strip and a 45-degree angle between the back strips. The patient is asked to place his foot on the side to be tested at the intersection of the lines. The patient gently touches the anterior, posteriolateral, posteromedial directions with the other foot and brings it back to the fixed leg. During this time, care is taken not to lift the heel of the other foot. If the balance is disrupted, the test is canceled and repeated. The point where the foot touches is marked and the distance to the intersection point is recorded in centimeters. The test is repeated 3 times and the average is recorded., Six week
Secondary Outcome Measures: Change from Baseline in Proprioception on the Joint Position Sense Test, Digital inclinometer; It is a device that is simple to use, affordable, portable, and makes quick measurements compared to expensive and complex equipment. Joint position sense is evaluated by the patient actively moving the extremity to the specified angle. The digital inclinometer is fixed on the limb using a strap. The patients' full range of motion in the joint to be evaluated is measured and 50% of these angles are selected as the target position. The therapist brings the person to the target position and asks him to stop there for 5 seconds and focus on the point he is in, then return to the starting position. This movement is repeated 3 times for the patient to learn the position. During the test, the participants' eyes are covered with an eye patch. Testing is performed when participants actively reposition the joint to the target position. When the participant feels that he/she has reached the target position, he/she stops and the test ends in the position where he/she stands, Six week|Change from Baseline in Functional Level on the 10 Meters Walking Test, The starting and finishing lines are determined in the 10 meter long test area. The time started when the participant walking at his own pace is at the starting line and ends at the finish line. The average value of three measurements is recorded in meters per second (m/s)., Six week|Change from Baseline in Functional Level on the Lower Extremity Functional Scale, The Lower Extremity Functional scale, which evaluates the functional level of individuals, consists of 20 questions. The Turkish validity and reliability of the scale was determined by Citaker et al. Answers to the questions; 0: Extreme difficulty or inability to perform the activity, 1: A great deal of difficulty, 2: Moderate difficulty, 3: Some difficulty, 4: No difficulty at all. An increase in the score indicates a better functional level., Six week|Change from Baseline in Edema on the Environmental Measurement Methods, Edema is evaluated based on certain reference points. Although it varies among clinicians, it is easy to use and common in the clinic. It is recommended that measurements be made by the same therapist. In a long sitting position, when the ankle is neutral, measurements are made with a tape measure at 5 centimeter intervals, using the malleolus as a reference. The volume is determined using the truncated cone formula with the obtained values. Frustum formula; V= \[h x (R1²+R1.R2+R2²)\] / (12 x π), Total Leg Volume=V1+V2+V3...+Vn (V: Volume of each conical segment, h: Range used in environmental measurement, R1: Base circumferential measurement of tapered segment, R2: Upper circumferential measurement of tapered segment, n: Number of conical segments)., Six week|Change from Baseline in Fear of Falling on the Falls Efficacy Scale International (FES-I), The Falls Efficacy Scale International assesses anxiety about the possibility of falling through activities. The Turkish validity and reliability study of the scale was conducted by Ulus et al. It was conducted by in 2012. The scale consists of 16 questions and is answered as 'I never worry (1 point)', 'I worry a little (2 points)', 'I worry quite a bit (3 points)' and 'I worry a lot (4 points)'. The total score is recorded, an increase in the score indicates an increase in the fear of falling., 6 week