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RECRUITING
NCT07472543
NA

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

Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-01

Completion Date

2026-10-01

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

PROCEDURE

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 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.

OTHER

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 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.

Locations (2)

Ankara Gaziler physical therapy and rehabilitationhospital

Ankara, Turkey (Türkiye)

Gaziler physical therapy and rehabilitation

Ankara, Turkey (Türkiye)