Effects of Insoles on Children With Developmental Delays

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

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

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.