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:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT05408156
Eligibility Criteria:
Inclusion Criteria:
* Individuals of both sexes aged over 18 years;
* Presence of mild to moderate hallux valgus, according to the Manchester scale;
* Presenting no hallux with intensity greater than or equal to 3 points up to 8 points, according to the Numerical Pain Scale (END);
* Be available to actively use the insole for at least 4 hours/day;
* Commitment to wear closed shoes, for example (sneakers, shoes used by the patient, due to: wide toe cap and heel height of 2 to 3 cm) during the study.
Exclusion Criteria:
* Being in physical therapy treatment for hallux valgus concomitantly with the research;
* Previous hallux valgus surgeries performed in the last 5 years;
* Presence of foot wounds and wounds, dislocations or metatarsophalangeal fractures in the foot with HV, in the last 5 years
* Presence of diseases such as rheumatoid arthritis, decompensated diabetes, gout, neurodegenerative diseases;
* Cognitive and mental disorder being unable to respond; those related to the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05408156
Study Brief:
Protocol Section:
NCT05408156