Effects of Insoles on Children With Developmental Delays

T

Taipei Medical University

Status

Unknown

Conditions

Developmental Delay

Treatments

Device: MEI BIN insoles

Study type

Interventional

Funder types

Other

Identifiers

NCT03191006
SKH-8302-106-DR-28.

Details and patient eligibility

About

Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

3 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

developmental delays

Exclusion criteria

age less than 3 years old or older than 10 years old normal development

Trial design

52 participants in 2 patient groups

study group: MEI BIN insoles
Active Comparator group
Description:
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.
Treatment:
Device: MEI BIN insoles
control group: without MEI BIN insoles
No Intervention group
Description:
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.

Trial contacts and locations

0

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Central trial contact

Ru-Lan Hsieh, MD

Data sourced from clinicaltrials.gov

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