Intermittent Claudication
Conditions
Interventions
This is a single-blind, two-arm randomized crossover clinical trial. An eligible sample of 10 participants for each condition (with and without the Eleva® functional electrical stimulation orthosis) w
intervention conditions). On the first evaluation day (estimated duration of 2 hours), anthropometric measurements and demographic information will be collected first—a procedure performed only once.
Sponsors
Universidade de Santa Cruz do Sul - UNISC
Pontifícia Universade Católica - PUCRS
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Patients of both sexes and aged between 18 and 90 years; bilateral or unilateral peripheral arterial disease in Fontaine stage II with an ankle-brachial index equal to or less than 0.9 in the last 6 months; presenting with intermittent claudication, determined through the Edinburgh Questionnaire; clinically diagnosed femoropopliteal occlusive disease, with absence of thigh and buttock claudication; body mass index between 18.5 and 24.9 kg/m2 (normal weight), between 25.0 and 29.9 kg/m2 (overweight), and between 30.0 and 34.9 kg/m2 (class I obesity); absence of severe comorbidities that could interfere with the study
Exclusion criteria
Exclusion criteria: Acute coronary syndrome within 3 months of onset; chronic limb-threatening ischemia; presence of a pacemaker or other implanted devices; diagnosis of severe infections; significant pulmonary disease or heart failure; maximum walking time of less than 60 seconds or greater than 840 seconds in the modified Gardner treadmill test; presentation of contraindications to physical exercise testing, as described in current cardiac rehabilitation guidelines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An increase in maximum walking distance, obtained through the modified Gardner protocol, is expected with the use of the device, based on the observation of a variation of at least 10% between the control and intervention conditions;An increase in maximum walking distance, obtained through the 6-Minute Walk Test, is expected with the use of the device, based on the observation of a variation of at least 10% between the control and intervention conditions | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in gait parameters, including cadence, gait speed, step length, stride length, stance time, swing time, and double-support phase, as assessed by accelerometry, is expected when using the device compared with the control condition;A relationship between static balance, as assessed by the Romberg test, and greater maximum walking distance, as assessed using the modified Gardner treadmill protocol, is expected;A relationship between functional independence, as assessed by the Functional Independence Measure, and greater maximum walking distance, as assessed by the Six-Minute Walk Test, is expected;A positive user comfort evaluation of the functional electrical stimulation orthosis is expected, as assessed using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0), with participants achieving a score of at least 4 ("quite satisfied") on each questionnaire item | — |
Countries
BR
Contacts
Public ContactDannuey Cardoso
Universidade de Santa Cruz do Sul - UNISC
Outcome results
None listed