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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT07075367
Eligibility Criteria:
Inclusion Criteria:
* Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2;
* DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
* Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
* Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
* Absence of diabetic foot ulcer (DFU) for at least one month
* No amputation or at most amputation of fingers, except for the hallux
Exclusion Criteria:
* Individuals involved in physical training programs simultaneously with the intervention
* History of surgical intervention in the lower limbs or spine
* Use of walking assistance devices
* Diagnosis of severe cardiovascular disorder
* Diagnosis of other neurological impairments in addition to DPN
* Presence of dementia or inability to provide consistent information
* Severe retinopathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT07075367
Study Brief:
Protocol Section:
NCT07075367