Therapeutic Effects of Customized Insoles on Children With Flat Foot
- Conditions
- Flat Foot
- Interventions
- Device: ICB Medical insoles
- Registration Number
- NCT02414087
- Lead Sponsor
- Taipei Medical University
- Brief Summary
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch-support shoe insoles to children with flat foot.
- Detailed Description
A total of 52 children with flat foot will be collected. The participants will be randomized into two groups, including study group (insoles group) and control group (without insole group).
All participants in the insoles group will be evaluated at baseline, that is before the customized full-length shoe insoles are prescribed. All the evaluations, including physical functional ability, balance, physical activity, functional performance, and quality of life will be re-evaluated up to 12 weeks after shoe insoles wearing in the insoles group.
The control group will be evaluated at the baseline and up to 12 weeks.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
- flat foot
- age less than 3 years old or older than 10 years old
- pathological flat foot
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group ICB Medical insoles ICB Medical Insoles
- Primary Outcome Measures
Name Time Method health related quality of life (Pediatric Quality of Life Inventory (PedQoL) baseline and up to 12 weeks Pediatric Quality of Life Inventory (PedQoL)
- Secondary Outcome Measures
Name Time Method functional performance (Pediatric Outcome Data Collection Instrument) baseline and up to 12 weeks Pediatric Outcome Data Collection Instrument
Trial Locations
- Locations (1)
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan