Use of the Unstable Shoes in Lower Limb Lymphedema.

• ClinicalTrials.gov Identifier: NCT05996939
• Recruitment Status: Completed
• First Posted: August 18, 2023
• Last Update Posted: August 18, 2023
• Sponsor: Universidad Europea de Madrid
• Information provided by (Responsible Party): Vanesa Abuín, Universidad Europea de Madrid

Tracking Information

• First Submitted Date: July 28, 2023
• First Posted Date: August 18, 2023
• Last Update Posted Date: August 18, 2023
• Actual Study Start Date: November 1, 2013
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 10, 2023)

Volume of the lower limb [ Time Frame: 8 weeks ]

Volume of the lower limb

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 10, 2023)

• Circumference measure of the foot [ Time Frame: 8 weeks ]
  Circumference measure of the foot
• Changes in lymphedema symptoms [ Time Frame: 8 weeks ]
  Changes in lymphedema symptoms

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Use of the Unstable Shoes in Lower Limb Lymphedema.
• Official Title: Effectiveness of Unstable Shoes on Volume and Quality of Life in Lower Limb Lymphedema.
• 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.

Detailed Description

Participants Subjects were recruited amongst the members of a Spanish association of people affected with lymphedema. Inclusion criteria were a) Subjects affected with lower limb lymphedema -primary, secondary, unilateral or bilateral-, b) Daily use of a compression stocking. Exclusion criteria were a) Subjects with acute infection of the affected limb b) that did not had any treatment for lymphedema one year prior to the study, c) Weight <40kg, d) shoe size <EU35 or >EU47 e)that have previously used unstable shoes f) vestibular alterations, vertigo, hypoacusis c) visual compromise that affects balance.

Procedure Written informed consent was obtained from the participants before the intervention. Random allocation to experimental and control group, was performed using Excel built-in function RAND ().. The generated sequence was employed to allocate the participants to one of the trial groups (e.g., intervention or control). Participants followed an 8 week intervention. Experimental group (EG) were provided with unstable sole shoes (MBT®, Masai Barefoot Technology Spain SL,08021 Spain.) and asked to wear them following a standardized protocol: 1 hour on day 1, increasing 1h each 2 days until 4h of daily use are achieved, during standing position and walking in the context of daily live activities, excluding sport activities. Control group (CG) was provided with a conventional sole sports footwear, following the same protocol that EG.

Outcome measures Circumferencial measure. Circumferencial measure was evaluated using a tape measure to measure the circumference of the foot at different points. Distal (4 cm from the base of the nail towards proximal) and Proximal (4 cm from the previous measurement).

Volume. Kuhnke's formula was used to calculate the estimated volume of the affected limb(241) V=(C12 + C22 +… Cn2)/π, Where V represents the volume and C refers to the different diameters of the limb, measured in centimeters.

Perception of the participants' clinical manifestations (243): measured through a questionnaire on perception of the state of the person's vascular alteration referred to the affected limb. In this survey, the subject is asked to value their symptoms (included heaviness, spider veins, swelling, pain, appearance of varicose veins, cramps, paresthesia and venous ulcers) with a 4-point scale: 0=absent, 1=mild/moderate, 2=important, 3=severe. In addition to lower limb swelling, other important symptoms experienced are heaviness, tightness, and pain. As there is no validated scale or survey to measure these symptoms characteristic of lymphedema, we used as a reference a previous study [10], where the symptoms or clinical manifestations compatible with chronic venous insufficiency that can be extrapolated to lymphedema are described.

In addition, a Change of habits survey was conducted at the end of the intervention period

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care
• Condition: Lower Limb Lymphedema

Intervention

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

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.

Study Arms

• Experimental: Unstable shoes
  Use of unstable shoes for 8 weeks
  Intervention: Other: To compare the efficacy of unstable shoes with that of conventional sports shoes in people with lower-limb primary and secondary lymphedema.
• No Intervention: Usual sports footwear
  Use of conventional shoes for 8 weeks

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 10, 2023): 26
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2017
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT05996939
• Other Study ID Numbers: UEM_LIN_2011_01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Vanesa Abuín, Universidad Europea de Madrid
• Original Responsible Party: Same as current
• Current Study Sponsor: Universidad Europea de Madrid
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universidad Europea de Madrid
• Verification Date: August 2023