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

NCT07472543 | Recruiting

• 1 other identifier: GaitVR-Lymphedema-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lymphedema; Gait Dysfunction; Physical Rehabilitation; Chronic Edema

Keywords

lymphedema; virtual reality exercises; ultrasonography; Gait Analysis; Spatiotemporal Parameters; Complex Decongestive Therapy (CDT)

Outcome Measures

Primary Outcomes (2)

• Gait parameters

  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.

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

• Lower extremity circumferential volume measurements

  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).

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

Secondary Outcomes (4)

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

  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)

  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)

  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)

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

Study Arms (2)

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.

Other: Complex Decongestive Therapy alone group

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

ACTIVE COMPARATOR

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.

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

Interventions

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

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.

Complex Decongestive Therapy alone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaziler Physical Medicine and Rehabilitation Education and Research Hospital: lead

Study Sites (2)

Ankara Gaziler physical therapy and rehabilitationhospital

Ankara, 06680, Turkey (Türkiye)

RECRUITING

Gaziler physical therapy and rehabilitation

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Lymphedema

Interventions

carbohydrate-deficient transferrin

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

SEFA GÜMRÜK ASLAN

CONTACT

+903122911503; sefagumrukk@gmail.com

sefa gümrük aslan, M.D.

CONTACT

+903122911503; sefagumrukk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be evaluated by an independent physiatrist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: March 16, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)