Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT04011267
Eligibility Criteria:
Inclusion Criteria:
* Diabetes mellitus type 1 or 2;
* Moderate or severe neuropathy confirmed with the fuzzy software;
* Ability to walk independently in the laboratory ;
* Accessibility to electronic devices (computers, mobile devices, tablets, etc.) access to exercise software.
Exclusion Criteria:
* Hallux amputation or total amputation of the foot;
* History of surgical procedure in the knee, ankle or hip;
* History of arthroplasty and / or lower limb orthosis or indication of lower limb arthroplasty throughout the intervention period;
* Neurological and / or rheumatologic diseases diagnosed;
* Inability to provide consistent information;
* Perform physiotherapy intervention throughout the intervention period;
* Receiving any physiotherapy intervention or offloading devices;
* Major vascular complications;
* Severe retinopathy;
* Ulceration not healed for at least 6 months and / or active ulcer;
* Score between 12-21 (Probable Depression) from the Hospital Anxiety and Depression Scale (HADS).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04011267
Study Brief:
Protocol Section:
NCT04011267