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NCT Number: NCT07472543

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

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.

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Key information

Conditions

Lymphedema Chronic Edema Gait Dysfunction Hemic and Lymphatic Diseases Lymphatic Diseases Physical Rehabilitation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Gaziler physical therapy and rehabilitationhospital, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Procedure

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.

Complex Decongestive Therapy alone group

Other

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.

Primary outcomes

  1. Gait parameters

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    Spatiotemporal gait parameters (walking speed, cadence, step length, stride length, stance time, swing time) and plantar pressure distribution (peak pressure and contact time in heel, midfoot, and forefoot regions) will be assessed using the Rehawalk® instrumented treadmill system (zebris Medical GmbH, Germany). All parameters will be reported as individual continuous variables. Participants will walk barefoot at self-selected comfortable speed; data will be recorded for 30-60 seconds during steady-state walking after 1-2 minutes adaptation.

  2. Lower extremity circumferential volume measurements

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    Circumferential measurements will be performed on the affected extremity with the patient in a semi-seated position, the ankle in neutral and the knee in extension. Measurements will begin at the ankle (medial malleolus) and continue at 4 cm intervals up to the inguinal region. After treatment, all patients' lymphedematous extremities (unilateral) will be measured a second time by the same evaluator using the same method, and the measurements will be recorded.

    The measurement data will be used to calculate the volume of the limb segments using the frustum formula for truncated cones, processed via Microsoft Excel. Pre- and post-treatment circumferential measurement data will be entered into the program to calculate extremity volumes and volume differences between extremities (in milliliters and percentage).

Secondary outcomes

  1. Dermal-epidermal thickness and subcutaneous tissue thickness measured by ultrasonography (USG)

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    Ultrasonographic evaluation will include measurement of the dermo-epidermal complex thickness, subcutaneous tissue thickness, and subcutaneous fluid accumulation. Additionally, sonographic pattern analysis will be performed to assess homogeneity, differences in echogenicity, fibrotic bands, and irregularities. Other findings such as lymphatic lakes and fascial delamination will also be evaluated.

  2. Quality of life assessment -Lymphedema Quality of Life Questionnaire-Leg (LYMQOL-Leg)

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    Lymphedema Quality of Life Questionnaire-Leg (LYMQOL-Leg): This is a disease-specific quality of life scale for patients with lymphedema, consisting of 22 questions organized into 4 sections.Each item is scored on a 4-point Likert scale. Domain scores range from 0 to 7, with higher scores indicating worse quality of life. An overall quality of life item is scored from 0 to 10, with higher scores indicating better overall quality of life.

  3. Functional capacity - Timed Up and Go Test (TUG)

    Time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).

    Functional capacity assessment using the Timed Up and Go Test (TUG). Timed Up and Go Test (TUG): This test measures the speed at which patients perform several functional maneuvers including standing up from a chair, walking, turning, and sitting down.

  4. Functional status - Lower Extremity Functional Scale (LEFS)

    Time frame: Measurements will be taken at baseline (before treatment) and after 4 weeks of treatment.

    Functional status will be evaluated using the Lower Extremity Functional Scale (LEFS). This questionnaire consists of 20 items assessing the patient's ability to perform daily activities involving the lower extremities. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 80, with higher scores indicating better functional condition.

Study contacts

Contact information is provided by the study sponsor or research team.

SEFA GÜMRÜK ASLAN

CONTACT

[email protected]

+903122911503

sefa gümrük aslan, M.D.

CONTACT

[email protected]

+903122911503

Sponsors and collaborators

Lead sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Other

Registry information

Official study title

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

Acronym: VR-LELO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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