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Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children
A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).
All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).
The control group were evaluated at baseline and up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group: MEI BIN insoles | Active Comparator | Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. |
|
| control group: without MEI BIN insoles | No Intervention | Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEI BIN insoles | Device | wearing insoles for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of baseline of level walking time to 12 weeks | time of level walking | baseline and up to 12 weeks |
| change of baseline of stairs climbing time to 12 weeks | time of stairs climbing | baseline and up to 12 weeks |
| change of baseline of up and go time to 12 weeks | time of up and go | baseline and up to 12 weeks |
| change of baseline of chair raising time to 12 weeks | time of chair raising | baseline and up to 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| change of baseline balance (scores) to 12 weeks | Berg balance test | baseline and up to 12 weeks |
| change of baseline functional performance(scores) to 12 weeks | Pediatric Outcome Data Collection instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh | Shin Kong Wu Ho-Su Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
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| baseline and up to 12 weeks |
| change of baseline quality of life (scores) to 12 weeks | Child Health Questionnaire-Parent form | baseline and up to 12 weeks |