NCT07472543 Impact of Virtual Reality (VR) Based Exercises on Lower Limb Lymphedema Outcomes (LELO)
| NCT ID | NCT07472543 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital |
| Condition | Lymphedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07472543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lymphedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07472543 currently recruiting?
Yes, NCT07472543 is actively recruiting participants. Contact the research team at sefagumrukk@gmail.com for enrollment information.
Where is the NCT07472543 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye), Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07472543 clinical trial?
NCT07472543 is sponsored by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital. The trial plans to enroll 40 participants.