Relationship Between Balance and Body Awareness in Lymphedema Patients

NCT07744906 | Completed DMC

• 1 other identifier: KayseriEAH
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphedema (LE) is a chronic condition caused by the accumulation of protein-rich fluid in the subcutaneous tissue as a result of insufficiency of the lymphatic system . Primary LE occurs due to an anomaly in the development of the lymphatic system, while secondary LE occurs as a result of subsequent damage to the lymph vessels or lymph nodes. The incidence of LE in the literature varies. It is thought that there are approximately 140-250 million patients with LE worldwide. While the incidence of LE is 1.4 in every 1000 people, primary LE accounts for one-fourth of this. Chronic inflammation, cellulitis, pain, fatigue, deformity, difficulty in movement, and difficulty in functional use of the affected extremity may occur due to untreated LE (5-6). Loss of joint mobility and developing asymmetry affect the individual's balance (7-9). To our knowledge, there are a limited number of studies evaluating lymphedema and balance (10-11). This study will evaluate individuals with unilateral edema in the lower extremity. We think that balance will be affected due to the increase in volume in the extremity, feeling the extremity heavy and feeling fullness. Body awareness is defined in physical therapy texts as a type of treatment aimed at awareness of how the body is used in terms of function, behavior and interaction with self-other (12-13). Body awareness includes attention directed to the body both in motion and motionless. It refers to awareness of both sensory inputs and motor control related to the integration of breath and movements, coordination and balance (14). Studies on body image in LE patients are also insufficient. As far as we can see, there is no study in the literature examining the relationship between balance and body awareness in lower extremity lymphedema patients with different lymphedema levels (mild, moderate, severe) according to objective assessment criteria in Turkish patients. In this study, our hypothesis is that balance and body awareness are more affected in patients with severe lymphedema compared to patients with mild and moderate lymphedema associated with secondary unilateral lower extremity lymphedema. Therefore, we aimed to compare female individuals with secondary unilateral lymphedema with healthy volunteer female individuals. Our study will include 28 female individuals with unilateral secondary lower extremity lymphedema who applied to Kayseri City Hospital, Physical Therapy and Rehabilitation Hospital between March 2023 and June 2023 and who meet the study criteria, and 28 healthy female individuals in the same age group. The sample group consisted of patients who had undergone lymphoscintigraphy in the past and were diagnosed with lymphedema as a result of scintigraphy and applied to Kayseri City Hospital, Physical Therapy and Rehabilitation Hospital for LE treatment. The "G\*Power 3.1" package program was used in the computer environment to evaluate the power and sample size of our study. As a result of the analysis, when the power is targeted as minimum 85% and the error amount is 0.05, the minimum sample size required to find a significant difference between the means has been determined as 28 individuals for each group (15). Individuals will be evaluated once. 1\. Maclellan RA, Couto RA, Sullivan JE, Grant FD, Slavin SA, Greene AK. Management of Primary and Secondary Lymphedema: Analysis of 225 Referrals to a Center. Ann Plast Surg. 2014; Aug;75(2):197-00. 2. Földi M, Földi E. Földi's textbook of lymphoLÖgy for physicians and lymphedema therapists (2nd ed.)Elsevier, Munich. 2006. 3. NLN Medical Advisory Committee. The diagnosis and treatment of lymphedema 2011. 4\. Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. 5. Andersen L, Hojris I, Erlandsen M, Andersen J. Treatment of breast-cancer-related lymphedema with or without manual lymphatic drainage--a randomized study. Acta Oncol. 2000;39(3):399-05. 6.Johansson K, Ingvar C, Albertsson M, Ekdahl C. Arm Lymphoedema, Shoulder Mobility and Muscle Strength after Breast Cancer Treatment ? A Prospective 2-year Study. Adv Physiother. 2001;3(2):55-66. 7\. Özkal Ö, Topuz S, Konan A, Kısmet K. Alt Ekstremite Yanık Yaralanması Olan Bireylerde Ağrı, Kinezyofobi, Denge Ve Fonksiyonellik Arasındaki İlişkinin İncelenmesi. Ankara Eğt. Arş. Hast. Derg. 2017;50(3):122-8. 8\. Truszczyńska A, Dobrzyńska M, Trzaskoma Z, Drzał-Grabiec J, Tarnowski A. Assessment of postural stability in patients with lumbar spine chronic disc disease. Acta of bioengineering and biomechanics. 2016;18(4):71-77. 9. Hassan B, Mockett S, Doherty M. Static postural sway, proprioception, and maximal voluntary quadriceps contraction in patients with knee osteoarthritis 68 and normal control subjects. Annals of the rheumatic diseases. 2011;60(6): 612-618. 10. Orhan C, et al. Meme Kanseri Tedavisiyle İlişkili Lenfödemi Olan Hastalarda Lenfödem Şiddetinin Yaşam Kalitesi, Üst Ekstremite Fonksiyon

Conditions

Balance in Lymphedema; Lymphedema

Keywords

lymphedema; balance; body awareness

Outcome Measures

Primary Outcomes (1)

• Balance assessment - Mini-Balance Assessment

  Balance Assessment: The Mini-Balance Assessment Systems Test (Mini-BESTest) was used for balance assessment. This test is used to assess dynamic balance. Mini-BESTest consists of 14 items grouped into four balance control domains: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each question receives a score between "0" and "2", and the total score is "28". The total score is obtained by summing the scores of each question. A high total score indicates good balance

  Each patient was assessed once for balance. The study was conducted between January 2025 and December 2025. Patients with secondary lymphedema who had been experiencing symptoms for at least 6 months were included in the study.

Secondary Outcomes (1)

• Assessment Of Body Awareness:

  Each patient was assessed once for body awareness. The study was conducted between January 2025 and December 2025. Patients with secondary lymphedema who had been experiencing symptoms for at least 6 months were included in the study.

Study Arms (2)

Relationship between balance and body awareness in lymphedema patients

lymphedema group

Diagnostic Test: mini best balance quaestionare; Other: Evaluation of body awareness

control group

healty control group

Diagnostic Test: mini best balance quaestionare; Other: Evaluation of body awareness

Interventions

mini best balance quaestionare DIAGNOSTIC_TEST

Balance assessment - Mini-Balance Assessment Systems Test will be used for balance assessment. This test is used in the assessment of dynamic balance. The test consists of a total of 14 items and this test has 4 subheadings: intuitive (standing up from sitting, rising on tiptoe, standing on one leg), reactive postural control (forward, backward and sideways compensatory step correction), sensory orientation (hard ground with eyes open, soft ground with eyes closed and sloping ground) and dynamic walking (change in walking speed, walking with head movements, turning, jumping over an obstacle, get up and go test with 2 tasks). Each question receives scores ranging from "0" to "2" and the total score is "28". The total score is obtained by adding the scores of each question. A high total score indicates that the balance is good.

Relationship between balance and body awareness in lymphedema patients; control group

Evaluation of body awareness OTHER

Individuals' body awareness will be evaluated with the Body Awareness Questionnaire (VFA), which was developed by Shields, Mallory \& Simon in 1989 and has been validated and reliable in Turkish. VFA is a questionnaire that aims to determine the normal or abnormal sensitivity level of body composition. It consists of four subgroups (attention to changes and reactions in body processes, sleep-wake cycle, estimation of the onset of the disease, estimation of body reactions) and a total of 18 statements. The participant is asked to score each statement with numbers from one to seven (1= Not true for me at all, 7= Completely true for me). The rating in the questionnaire is made as a total score. The maximum total score to be received from the questionnaire can be 126 and the minimum is 18. The higher the total score to be received from the questionnaire, the better the body awareness is concluded.

Relationship between balance and body awareness in lymphedema patients; control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Only female patients were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included individuals diagnosed with lymphedema who applied to the physical therapy and rehabilitation clinic of XXX Hospital, as well as healthy volunteers with similar age and gender characteristics.

You may not qualify if:

• \- Those with any mental problems that will prevent cooperation and understanding,
• Those who are illiterate,
• Those with orthopedic and rheumatological diseases,
• Those who do not want to participate in the study voluntarily,
• Those with neurological diseases will not be included in the study,
• Having a history of metastasis,
• Having another disease that will affect balance.

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Kayseri City Hospital

Kayseri, Kocasinan, 38800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kayseri City Hospital

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 4, 2026
• Study Start: January 1, 2025
• Primary Completion: December 15, 2025
• Study Completion: December 30, 2025
• Last Updated: August 4, 2026

Record last verified: 2025-08

Locations

TU (1)