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

Официальное название

The Effect of Virtual Reality-Assisted Exercises on Gait Parameters, Function, Quality of Life, and Edema Level in Patients With Lower Extremity Lymphedema

Обзор

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.

Вмешательства

• Процедура Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group
  The intervention group will receive standard Complex Decongestive Therapy (CDT) combined with virtual reality (VR)-supported walking exercises using the Rehawalk device. The Rehawalk system, which provides visual and auditory step guidance within a virtual environment, will be used to conduct the walking exercises at Gaziler Physical Therapy and Rehabilitation Training and Research Hospital. Participants will perform the VR-supported walking exercises for 20 minutes, five days a week, under the
• Другое Complex Decongestive Therapy alone group
  The control group will receive only the standard Complex Decongestive Therapy (CDT). This treatment will be administered daily and consists of manual lymphatic drainage for 20 minutes, multi-layer compression bandaging for 10 minutes, skin and nail care for 5 minutes, patient education for 5 minutes, and therapeutic exercises including joint range of motion, stretching, and breathing exercises for 20 minutes. No virtual reality or additional gait training interventions will be applied to this gr

Первичные конечные точки

• Gait parameters [Срок оценки: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).]
• Lower extremity circumferential volume measurements [Срок оценки: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).]

Вторичные конечные точки (4)

• Dermal-epidermal thickness and subcutaneous tissue thickness measured by ultrasonography (USG) [Срок оценки: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).]
• Quality of life assessment -Lymphedema Quality of Life Questionnaire-Leg (LYMQOL-Leg) [Срок оценки: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).]
• Functional capacity - Timed Up and Go Test (TUG) [Срок оценки: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).]
• Functional status - Lower Extremity Functional Scale (LEFS) [Срок оценки: Measurements will be taken at baseline (before treatment) and after 4 weeks of treatment.]

Критерии участия

Критерии включения

• Age between 18 and 65 years
• Diagnosis of unilateral lower extremity lymphedema following gynecological and/or oncological surgery
• Stage 2 or 3 lymphedema

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 2 центра

• Ankara Gaziler physical therapy and rehabilitationhospital — Ankara
• Gaziler physical therapy and rehabilitation — Ankara

Идентификаторы

NCT: NCT07472543 · GaitVR-Lymphedema-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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