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Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema

Effectiveness of Digital Physiotherapy in the Short and Long-Term Management of Lower Extremity Lymphedema

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07014566
Enrollment
82
Registered
2025-06-11
Start date
2019-02-05
Completion date
2024-11-22
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Extremity Lymphedema

Keywords

Lower extremity lymphedema, Digital physiotherapy, Combined decongestive therapy

Brief summary

This study investigated the short- and long-term effects of digital physiotherapy in patients with unilateral and bilateral lower extremity lymphedema. Limb volume and quality of life were assessed at baseline, post-treatment, and 12-week follow-up.

Detailed description

This study evaluated the feasibility and effectiveness of a digital physiotherapy program based on combined decongestive therapy in patients with lower extremity lymphedema. After an initial face-to-face training session on self-bandaging, self-manual lymphatic drainage, breathing exercises, and skin care, patients followed a 4-week digital physiotherapy program with remote supervision. Compression stockings were used during the maintenance phase. Limb volume was measured using circumference method. Quality of life was assessed with the Lymphoedema functioning, disability and health questionnaire questionnaire. Assessments were repeated post-treatment and at 12-week follow-up.

Interventions

The intervention consisted of a digitally delivered combined decongestive therapy (CDT) program for patients with unilateral or bilateral lower extremity lymphedema. Patients attended a single face-to-face session where a physiotherapist provided training on skin care, self-bandaging, self-manual lymphatic drainage, and therapeutic exercises (breathing, gluteal sets, knee sets, and toe movements). Caregivers recorded the demonstrations for home use. Following this session, a 4-week remote physiotherapy program was implemented using telecommunication technologies. Patients continued self-management with guidance via digital platforms. Compression stockings replaced self-bandaging during the 12-week follow-up phase.

Sponsors

Bezmialem Vakif University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Diagnosed with unilateral lower extremity lymphedema (either primary or secondary) * Patients aged 18 years or older

Exclusion criteria

* Presence of metastatic disease * History of coronary heart disease, pulmonary disease, or acute infection of any cause * Presence of peripheral neuropathy

Design outcomes

Primary

MeasureTime frameDescription
Change in Limb VolumeAt baseline, at week 4 (end of treatment), and at week 12 (follow-up)Limb volume was assessed by measuring the circumference of the affected arm at 4-cm intervals from the ulnar styloid to the axillary region using a standard tape measure. These measurements were used to calculate the total limb volume to evaluate changes after the intervention and at follow-up.

Secondary

MeasureTime frameDescription
Change in Quality of LifeAt baseline, at week 4 (end of treatment), and at week 12 (follow-up)Quality of life was assessed using the Turkish version of the Lymphedema Functioning, Disability and Health Questionnaire (Lymph-ICF), which is specific to lymphedema. The scale consists of 29 items across five domains: physical function, mental function, household activities, mobility activities, and social life. Each item was scored on a 0-100 mm visual analog scale (VAS), where higher scores indicate greater impairment and reduced quality of life.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026