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Balance in LymphedemaNCT07744906

Relationship Between Balance and Body Awareness in Lymphedema Patients

An observational study of Balance in Lymphedema and Lymphedema, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years, women onlyHealthy volunteers can take part
Conditions the study is for
Balance in Lymphedema, Lymphedema
What is being tested?
mini best balance quaestionare and Evaluation of body awareness
How many people
61 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2025to 30 Dec 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

None listed.

Who cannot join

  • - 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kayseri City Hospital

    Kayseri, Kocasinan, 38800

Other trials in Turkey (Türkiye)

About this study

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.

Read more

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.

  1. 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.

  1. 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.
  2. 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

Read the detailed description

Evaluation Parameters Sociodemographic characteristics of individuals will be questioned with the general evaluation form for all participants, and body awareness and balance functions will be evaluated once.

The general evaluation form includes the participant's name-surname, date of birth, gender, height, weight and evaluation parameters. The severity of edema was determined according to the criteria determined by the American Physical Therapy Association. Accordingly;

  • If the circumference difference between both extremities is between 2-3 cm, it will be recorded as mild,
  • If it is between 3-5 cm, it will be recorded as moderate,
  • If it is over 5 cm, it will be recorded as severe LÖ.

Evaluation of body awareness Individuals' body awareness will be evaluated with the Body Awareness Questionnaire (BQQ) developed by Shields, Mallory \& Simon in 1989, which 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, prediction at the beginning of the disease, prediction 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 score to be obtained from the questionnaire can be 126 and the minimum is 18. As the total score to be obtained from the questionnaire increases, it is concluded that body awareness is better.

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
Being tested
mini best balance quaestionare, Evaluation of body awareness
Keywords
lymphedema, balance, body awareness
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mini best balance quaestionareDiagnostic 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.

  • Evaluation of body awarenessOther

    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.

Study groups in NCT07744906
Study groupRoleWhat they receive
Relationship between balance and body awareness in lymphedema patientslymphedema group
Receives: Diagnostic Test: mini best balance quaestionare; Other: Evaluation of body awareness
control grouphealty control group
Receives: Diagnostic Test: mini best balance quaestionare; Other: Evaluation of body awareness

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  1. Assessment Of Body Awareness:

    Assessment Of Body Awareness: Body awareness was assessed using the Body Awareness Questionnaire (BAQ), originally developed by Shields, Mallory, and Simon in 1989. The Turkish version of the questionnaire has demonstrated satisfactory validity and reliability. The BAQ is a questionnaire designed to determine the level of sensitivity to normal or abnormal body composition. It consists of four subgroups (Attention to changes and responses in body processes, sleep-wake cycle, prediction of disease onset, prediction of body responses) and a total of 18 statements. Participants are asked to rate each statement on a scale of one to seven (1 = Not true at all for me, 7 = Completely true for me). The rating is done as a total score. The maximum total score from the questionnaire can be 126, and the minimum can be 18. A higher total score from the questionnaire indicates better body awareness

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2026
  2. Study start1 Jan 2025
  3. Primary completion15 Dec 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
61 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07744906
Sponsor's protocol ID
KayseriEAH
Status last verified
Aug 2025
First submitted
14 Jul 2025
Last updated
4 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Balance in Lymphedema and Lymphedema, run by Kayseri City Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance assessment - Mini-Balance Assessment (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.

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