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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT01839669
Eligibility Criteria:
Inclusion Criteria:
* Age: 18-60
* Current complaint of foot and ankle pain that lasted for 3 months or more
* Flexible Pes planovalgus deformity in the clinical assessment
* Posterior tibial tendon dysfunction (PTTD) of stage I and II (Johnson \& Strom 1989)
* Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph (Younger 2005): Lateral view: lateral talo-first metatarsal angle ≠ 0° (break of axis): angle \>10° according to Younger (2005); 60Anteroposterior view: anteroposterior talo-first metatarsal angle ≠ 0° (break of axis): angle \>10° according to Younger (2005)
* "too-many toes"-sign from rear frontal view with an abducted forefoot (Johnson \& Strom 1989, Kulig 2009b)
* Eligibility for non-surgical treatment
* No indication / not yet an indication for surgical treatment of foot deformity
Exclusion Criteria:
* Rigid foot deformity
* Posterior tibial tendon dysfunction (PTTD) of stage III and IV according to Johnson \& Strom 1989 (=\>rigid foot deformity)
* Cardio-, neuro-, or peripheral vascular pathology, musculoskeletal pathology, acute infection or alcohol addiction limiting participation in study protocol
* Acute use of local or systemic analgesics
* Acute physical therapy, training therapy or physiotherapy
* Acute overuse or traumatic injury to the lower leg (excluding Pes planovalgus associated pathology)
* Prior surgery to the lower limb
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01839669
Study Brief:
Protocol Section:
NCT01839669