Developmental Delay
Conditions
Keywords
effect, insoles, children
Brief summary
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
Detailed description
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.
Interventions
DEVICEMEI BIN insoles
insoles
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
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
No
Inclusion criteria
* developmental delays
Exclusion criteria
* age less than 3 years old or older than 10 years old normal development
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline functional performance (scores) at 12 weeks | baseline and up to 12 weeks | Pediatric Outcome Data Collection Instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change from baseline physical function (time) at 12 weeks | baseline and up to 12 weeks | time of stair climbing, timed up and go, walking on level ground |
| change from baseline balance (scores) at 12 weeks | baseline and up to 12 weeks | Berg balance scale |
| change from baseline quality of life at 12 weeks | baseline and up to 12 weeks | Pediatric Quality of Life inventory (PedsQL) |
Countries
Taiwan
Contacts
Primary ContactRu-Lan Hsieh, MD
Outcome results
None listed