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| Name | Class |
|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | OTHER |
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Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).
The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.
The control group will be evaluated at the baseline and up to 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group: MEI BIN insoles | Active Comparator | Participants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. |
|
| control group: without MEI BIN insoles | No Intervention | Participants in this control group will not receive a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEI BIN insoles | Device | insoles |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline functional performance (scores) at 12 weeks | Pediatric Outcome Data Collection Instrument | baseline and up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline physical function (time) at 12 weeks | time of stair climbing, timed up and go, walking on level ground | baseline and up to 12 weeks |
| change from baseline balance (scores) at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru-Lan Hsieh, MD | Contact | 228332211 | M001052@ms.skh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ru-Lan Hsieh, MD | Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shin Kong Wu Ho-Su Memorial Hospital | Taipei | 111-01 | Taiwan |
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| ID | Term |
|---|---|
| D007859 | Learning Disabilities |
| ID | Term |
|---|---|
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Berg balance scale
| baseline and up to 12 weeks |
| change from baseline quality of life at 12 weeks | Pediatric Quality of Life inventory (PedsQL) | baseline and up to 12 weeks |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |