Normal Development
Conditions
Keywords
therapeutic effects, insoles, children
Brief summary
Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children
Detailed description
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.
Interventions
DEVICEMEI BIN insoles
wearing insoles for 12 weeks
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks
Exclusion criteria
* age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of baseline of up and go time to 12 weeks | baseline and up to 12 weeks | time of up and go |
| change of baseline of level walking time to 12 weeks | baseline and up to 12 weeks | time of level walking |
| change of baseline of stairs climbing time to 12 weeks | baseline and up to 12 weeks | time of stairs climbing |
| change of baseline of chair raising time to 12 weeks | baseline and up to 12 week | time of chair raising |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change of baseline functional performance(scores) to 12 weeks | baseline and up to 12 weeks | Pediatric Outcome Data Collection instrument |
| change of baseline quality of life (scores) to 12 weeks | baseline and up to 12 weeks | Child Health Questionnaire-Parent form |
| change of baseline balance (scores) to 12 weeks | baseline and up to 12 weeks | Berg balance test |
Countries
Taiwan
Outcome results
None listed