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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGaziler Physical Medicine and Rehabilitation Education and Research Hospital

About this trial

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

Qualifiers

Age between 18 and 65 years

Diagnosis of unilateral lower extremity lymphedema following gynecological and/or oncological surgery

Stage 2 or 3 lymphedema

Disqualifiers

Decompensated heart, lung, or kidney failure

Uncontrolled hypertension

Presence of systemic infection

Local infections in the lower extremity such as erysipelas or cellulitis

Trial design

Treatments tested in this trial

  • Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group
  • Complex Decongestive Therapy alone group

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

2
Ankara Gaziler physical therapy and rehabilitationhospital06680, Ankara Turkey (Türkiye)
Gaziler physical therapy and rehabilitation Ankara Turkey (Türkiye)

Sponsors and collaborators

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Lead sponsor