Effects of Insoles on Children With Developmental Delays

NCT ID: NCT03191006

Last Updated: 2017-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-24

Study Completion Date

2017-12-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Developmental Delay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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study group: MEI BIN insoles

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.

Group Type ACTIVE_COMPARATOR

MEI BIN insoles

Intervention Type DEVICE

insoles

control group: without MEI BIN insoles

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MEI BIN insoles

insoles

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* developmental delays

Exclusion Criteria

* age less than 3 years old or older than 10 years old normal development
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ru-Lan Hsieh

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ru-Lan Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Locations

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Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ru-Lan Hsieh, MD

Role: CONTACT

228332211

Other Identifiers

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SKH-8302-106-DR-28.

Identifier Type: -

Identifier Source: org_study_id

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