RecruitingNot ApplicableNCT07472543

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

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

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lymphedema Gait Dysfunction

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

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

Exclusion Criteria14

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)

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Interventions

PROCEDUREComplex 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 supervision of a physiotherapist. During these exercises, the affected lower limb will be multi-layer bandaged according to the standard CDT protocol. This combined treatment approach aims to improve gait parameters, functional capacity, edema control, and overall quality of life. Assessments will be carried out before and after the 4-week treatment period to evaluate the added benefits of VR-supported walking exercises alongside standard CDT.

OTHERComplex 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 group. Assessments will be conducted before and after the 4-week treatment period to evaluate the effects of CDT alone on functional capacity, quality of life, edema levels, and walking parameters.