LymphedemaVR-LELONCT07472543
Impact of Virtual Reality (VR) Based Exercises on Lower Limb Lymphedema Outcomes (LELO)
A study testing Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group and Complex Decongestive Therapy alone group in people with Lymphedema and Gait Dysfunction, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphedema, Gait Dysfunction, Physical Rehabilitation
- What is being tested?
- Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group and Complex Decongestive Therapy alone group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Diagnosis of unilateral lower extremity lymphedema following gynecological and/or oncological surgery
- Stage 2 or 3 lymphedema
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Gaziler physical therapy and rehabilitationhospital
Ankara, 06680
Sefa Gumruk Aslan, +903122911503, sefagumrukk@gmail.com
- Recruiting
Gaziler physical therapy and rehabilitation
Ankara
SEFA GÜMRÜK ASLAN, +903122911503, sefagumrukk@gmail.com
About 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
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
- Being tested
- Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group, Complex Decongestive Therapy alone group
- Keywords
- lymphedema, virtual reality exercises, ultrasonography, Gait Analysis, Spatiotemporal Parameters, Complex Decongestive Therapy (CDT)
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training groupProcedure or surgery
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Measurements will be taken at baseline (before treatment) and after 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472543
- Sponsor's protocol ID
- GaitVR-Lymphedema-2025
- Acronym
- VR-LELO
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07472543
- Acronym / sponsor ID
- VR-LELO / GaitVR-Lymphedema-2025
- Conditions
- Lymphedema, Gait Dysfunction, Physical Rehabilitation, Chronic Edema
- Keywords
- lymphedema, virtual reality exercises, ultrasonography, Gait Analysis, Spatiotemporal Parameters, Complex Decongestive Therapy (CDT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Decongestive Therapy alone group | Other | Other: Complex Decongestive Therapy alone groupThe 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 (CDT) plus virtual reality (VR)-assisted gait training group | Active comparator | Procedure: Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training groupThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years
- Diagnosis of unilateral lower extremity lymphedema following gynecological and/or oncological surgery
- Stage 2 or 3 lymphedema
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training groupThe 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 or surgery | Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group |
| Complex Decongestive Therapy alone groupThe 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 |
Primary outcome
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.
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).
4 secondary outcomes
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).
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).
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 status - Lower Extremity Functional Scale (LEFS)
Time frame: Measurements will be taken at baseline (before treatment) and after 4 weeks of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex Decongestive Therapy (CDT) plus virtual reality (VR)-assisted gait training group and Complex Decongestive Therapy alone group in people with Lymphedema and Gait Dysfunction, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEFA GÜMRÜK ASLAN (+903122911503, sefagumrukk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameters (time frame: Assessments will be conducted immediately before the treatment starts and at the end of the treatment (week 4).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.