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 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT01342458
Eligibility Criteria:
Inclusion Criteria:
* Kellgren and Lawrence grade 2 or 3
* Being able to walk independently for at least 6 hours per day without the aid of canes or attendant to perform their activities of daily living
* Knee pain between 3 and 8 on the visual analogue scale
Exclusion Criteria:
* Previous history of surgery on knees, ankles and hips in the last 2 years
* Neurological disease
* BMI \> 35 kg/m2
* Difference in lower limb length \> 1 cm
* Prostheses and / or lower limb orthoses
* Having received steroid injections and hyaluronic acid intra-articular knee in previous periods of three and six months respectively
* Present at the knee joint instability (positive test results in the medial collateral ligament, lateral, anterior and posterior drawer)
* OA of the hip and / or ankle incapacitating or diagnosed OA in lower limbs and spine
* Inflammatory arthritis (eg. rheumatoid arthritis)
* Asymptomatic OA of one or both knees
* Dementia or inability to provide consistent information
* Introduction of Nonsteroidal Anti-inflammatory Drugs and analgesic medications 8 weeks before inclusion or change of dosage of the same after the inclusion
* Being under physiotherapy or acupuncture treatment
* Patients with an indication of prosthesis or orthosis
* Patients who are already using a flexible and non-heeled shoes for more than 25 hours per week (3 ½ hours per day) over the past 6 months
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT01342458
Study Brief:
Protocol Section:
NCT01342458