RecruitingNot Applicable

Impact of Virtual Reality (VR) Based Exercises on Lower Limb Lymphedema Outcomes (LELO)

Turkey (Türkiye)40 participantsStarted 2025-09-01

Plain-language summary

This randomized controlled study aims to investigate the effects of virtual reality (VR)-assisted gait training, in addition to Complex Decongestive Therapy (CDT), on gait parameters, physical function, quality of life, and edema levels in patients with lower extremity lymphedema. Lymphedema is a progressive condition characterized by the accumulation of protein-rich fluid due to lymphatic drainage insufficiency, leading to chronic inflammation and fibrosis. It impairs gait patterns and reduces functional mobility. VR technologies, such as the RehaWalk system, provide interactive, personalized rehabilitation environments that enhance motor learning, motivation, and adherence to treatment. The study evaluates spatiotemporal gait parameters, three-zone foot analysis (heel, midfoot, forefoot), limb circumferences, ultrasound measurements (dermis, epidermis, subcutaneous fat thickness), and patient-reported outcomes. VR-based training offers a novel, engaging approach to improve physical rehabilitation outcomes in patients with lower limb lymphedema. No significant risks are expected in this study.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 65 years * Diagnosis of unilateral lower extremity lymphedema following gynecological and/or oncological surgery * Stage 2 or 3 lymphedema Exclusion Criteria: * Decompensated heart, lung, or kidney failure * Uncontrolled hypertension * Presence of systemic infection * Local infections in the lower extremity such as erysipelas or cellulitis * Venous insufficiency (e.g., deep vein thrombosis) * Any neuromuscular or orthopedic disease affecting lower extremity walking * Presence of balance disorders * Bilateral lymphedema * Presence of lipolymphedema * Fracture in the lower extremity * Active metastasis * Speech or language problems * Pregnancy * Inability to continue treatment (5 days a week for a total of 4 weeks)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gait parameters

Timeframe: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

Lower extremity circumferential volume measurements

Timeframe: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

Trial details

NCT IDNCT07472543

SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

SEFA GÜMRÜK ASLAN

+903122911503 sefagumrukk@gmail.com

View on ClinicalTrials.gov More Lymphedema trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Gait parameters

Timeframe: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

Lower extremity circumferential volume measurements

Timeframe: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).