Use of the Unstable Shoes in Lower Limb Lymphedema.

NCT05996939 | Completed

• 1 other identifier: UEM_LIN_2011_01
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Lymphedema is an external manifestation of lymphatic system insufficiency and deranged lymph transport. It is defined as accumulation in the extracellular space of protein-rich fluid, due to a mechanical failure of the lymphatic system. Lymphedema directly affects the quality of life of the patient, not only in the physical aspect, but also in the psychological, sexual and social aspects. Muscle and joint pumps are important external mechanisms of lymphatic and venous fluid return improvement. The unstable shoes demands, especially during standing, increased muscle activity in the lower extremities. A clinical trial was carried out comparing both kinds of footwear, the objective being to evaluate possible differences in the evolution of lymphedema. Unstable shoes (MBT®) were compared with conventional sports shoes. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema. The results suggested that the use of unstable shoes is recommendable for walking and for long periods of standing, since it decreases leg cramping and paraesthesia of affected limbs.

Conditions

Lower Limb Lymphedema

Outcome Measures

Primary Outcomes (1)

• Volume of the lower limb

  Volume of the lower limb

  8 weeks

Secondary Outcomes (2)

• Circumference measure of the foot

  8 weeks

• Changes in lymphedema symptoms

  8 weeks

Study Arms (2)

Unstable shoes

EXPERIMENTAL

Use of unstable shoes for 8 weeks

Other: To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.

Usual sports footwear

NO INTERVENTION

Use of conventional shoes for 8 weeks

Interventions

To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema. OTHER

Unstable shoes were compared with conventional sports shoes, the objective being to evaluate possible differences in the evolution of lymphedema. During a clinical trial lasting eight weeks, we assessed quality of life, limb volume, and symptoms derived from lymphedema.

Unstable shoes

Eligibility Criteria

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

You may qualify if:

• Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, -Daily use of a compression stocking

You may not qualify if:

• Subjects with acute infection of the affected limb
• that did not had any treatment for lymphedema one year prior to the study,
• Weight \<40kg,
• shoe size \<EU35 or \>EU47
• that have previously used unstable shoes
• vestibular alterations, vertigo, hypoacusis
• visual compromise that affects balanc

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 18, 2023
• Study Start: November 1, 2013
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2017
• Last Updated: August 18, 2023

Record last verified: 2023-08