Foot pain, functional impairments of the foot, and/or foot deformities in adults with long-term use of custom-made orthotic insoles.
Conditions
Interventions
Group 1: Participants allocated to the intervention group will take part in a structured home-based foot exercise programme over a period of 10 weeks. The programme aims to strengthen the intrinsic fo
Sponsors
Philipps-Universität Marburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Long-term use (= 6 months) of custom-made orthotic insoles prescribed by a physician and manufactured by an orthopaedic technician • Orthotic insoles prescribed for at least one of the following indications: pes planus, planovalgus deformity and/or splayfoot hallux valgus plantar fasciitis (with or without calcaneal spur) metatarsalgia (forefoot pain) non-specific foot pain • No foot pain on most days during the previous three months • Ability and willingness to participate in a structured home-based exercise programme • Sufficient German language skills to understand study procedures, questionnaires, and exercise instructions • Ability to provide written informed consent • Written informed consent provided prior to study participation
Exclusion criteria
Exclusion criteria: Participants will be excluded if any of the following criteria apply: • Severe congenital foot deformities (e.g. clubfoot or pes cavus) • Orthotic insoles prescribed primarily due to leg length discrepancy • Post-traumatic conditions or structural damage affecting the foot or ankle • Achilles tendon disorders or posterior heel pain (e.g. Haglund deformity) • Predominant musculoskeletal conditions outside the foot (e.g. knee, hip, or back disorders) that may substantially affect gait or participation in the intervention • Acute foot pain or inflammatory conditions of the lower extremity • Severe neurological or systemic diseases affecting foot function, mobility, or pain perception (e.g. advanced polyneuropathy or inflammatory rheumatic diseases)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Foot pain and function assessed using the German version of the Foot Function Index (FFI-D; Foot Function Index – German Version). The FFI-D total score (range 0–100; higher scores indicate greater pain and functional impairment) will be assessed at T0 (baseline) , T1 (10 weeks after baseline) and T2 (6-month follow-up) The primary analysis will be based on the difference in responder rates between groups. Participants will be classified as responders or non-responders according to predefined criteria derived from changes in the FFI-D total score between T0 and T1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity, assessed using a Visual Analogue Scale (VAS), at T0 (baseline), T1 (10 weeks), and T2 (6-month follow-up). Health-related quality of life, assessed using the EQ-5D-5L (EuroQol 5 Dimensions, 5 Levels), at T0, T1, and T2. Patient satisfaction with the assigned intervention, assessed using a study-specific questionnaire at T1. Adherence to the exercise programme and successful discontinuation of orthotic insole use, assessed through weekly self-reports and study-specific questionnaires during the intervention period and at T1 and T2. Foot morphology, assessed using the Foot Scan System (FS-Systeme, Germany). Parameters include foot length and the Chippaux-Smirak Index (CSI). Measurements will be performed at T0 (baseline), T1 (10 weeks), and T2 (6-month follow-up). Continuous changes in these parameters over time will be analysed. Health economic outcomes, including healthcare utilisation, direct and indirect costs, and quality-adjusted life years (QALYs), assessed using participant questionnaires and the EQ-5D-5L at T0, T1, and T2. Implementation-related outcomes (intervention reach, fidelity, dose, mechanism of impact, and contextual factors), assessed within a mixed-methods process evaluation using questionnaires and qualitative interviews following completion of the intervention (T1). | — |
Countries
Germany
Contacts
Public ContactAnnika Viniol
Philipps-Universität Marburg, Institut für Allgemeinmedizin
Outcome results
None listed