Virtual reality gait exercises for lower limb lymphedema (LELO)
The Effect of Virtual Reality-Assisted Exercises on Gait Parameters, Function, Quality of Life, and Edema Level in Patients With Lower Extremity Lymphedema
This trial will test whether adding VR-assisted gait training to standard Complex Decongestive Therapy helps adults with unilateral stage 2–3 lower limb lymphedema walk better, reduce swelling, and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Academic / other |
| Locations | 2 sites (Ankara and 1 other locations) |
| Trial ID | NCT07472543 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing Complex Decongestive Therapy (CDT) plus VR-assisted gait training (using systems such as RehaWalk) versus CDT alone in patients with unilateral lower extremity lymphedema. Participants undergo daily sessions five days a week for four weeks, with outcomes measured before and after treatment. Primary and secondary outcomes include spatiotemporal gait parameters, three-zone foot loading analysis, limb circumferences, ultrasound measurements of skin and subcutaneous tissue, and patient-reported function and quality of life. The trial is conducted at Gaziler Physical Medicine and Rehabilitation in Ankara and enrolls adults with stage 2–3 post-surgical lymphedema.
Who should consider this trial
Good fit: Ideal candidates are adults age 18–65 with unilateral stage 2 or 3 lower extremity lymphedema following gynecologic or oncologic surgery who can attend treatment five days per week for four weeks.
Not a fit: Patients with bilateral lymphedema, lipolymphedema, active infections, uncontrolled systemic disease, neuromuscular or orthopedic conditions that affect walking, active metastasis, pregnancy, or inability to adhere to the treatment schedule are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding VR gait training could improve walking function, reduce edema-related changes, and increase treatment engagement beyond standard CDT alone.
How similar studies have performed: VR-based gait and motor training have shown benefits for gait and engagement in other rehabilitation populations, but application specifically to lower limb lymphedema is relatively novel and limited in prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Ankara and 1 other locations
- Ankara Gaziler physical therapy and rehabilitationhospital — Ankara, Turkey (Türkiye) (Recruiting)
- Gaziler physical therapy and rehabilitation — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Sefa Gümrük Aslan
- Email: sefagumrukk@gmail.com
- Phone: +903122911503
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.