Therapeutic Effects of Customized Insoles on Children With Flat Foot
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|ClinicalTrials.gov Identifier: NCT02414087|
Recruitment Status : Unknown
Verified April 2015 by Ru-Lan Hsieh, Taipei Medical University.
Recruitment status was: Not yet recruiting
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Flat Foot||Device: ICB Medical insoles||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Therapeutic Effects of Customized Insoles on Children With Flat Foot|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: study group
ICB Medical Insoles
Device: ICB Medical insoles
Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months.
Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months
Placebo Comparator: control group
without ICB Medical insoles
- health related quality of life (Pediatric Quality of Life Inventory (PedQoL) [ Time Frame: baseline and up to 12 weeks ]Pediatric Quality of Life Inventory (PedQoL)
- functional performance (Pediatric Outcome Data Collection Instrument) [ Time Frame: baseline and up to 12 weeks ]Pediatric Outcome Data Collection Instrument
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414087
|Contact: Ru-Lan Hsieh, MD||886-2-28332211 ext 2538||M001052@ms.skh.org.tw|
|Shin Kong Wu Ho-Su Memorial Hospital|
|Taipei, Taiwan, 111-01|
|Principal Investigator:||Ru-Lan Hsieh, MD||Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University|