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The Balance Influence of Shoe Inserts on Motor Development Delayed Children

NCT ID: NCT02644317

Last Updated: 2015-12-31

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-31

Brief Summary

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Flatfoot, one of the most common foot problems experienced by preschool-aged children, characterized by the collapse of the foot's medial longitudinal arch. Children with motor developmental delay often have flatfoot, according to clinical observation, and research indicates that preschool age is the main stage of the medial longitudinal arch development period. There flatfoot symptoms due to poor arch shock effect, poor walking endurance, likely to cause gait problems while growing up. The lack of a stable foot structure to support and maintain posture may lead to delayed motor development. Early training intervention and help to balance stability is the main rehabilitation goal for motor developmental delayed children. With understanding of the foot development of motor development delayed children, proper intervention can be provided to improve the movement and stability of the lower limbs. The possible deformation of the foot structure and resultant pain in the future can also be prevented.

Detailed Description

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The investigators designed a prospective cohort study to long-time follow up of preschool aged children with delayed motor development and to establish standard data, including the foot shape, footprint and balance development. The investigators also discuss the influence of the shoe insert with balance and flatfoot correction. Flatfoot leads to poor gross motor balance and the balance improvement after flatfoot correction has never been studied. The investigators findings should provide direct evidence as a reference for clinical workers.

Conditions

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Development Delay

Keywords

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Motor development delay balance flatfoot shoe insert

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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with modified shoe inserts

wear the modified shoe inserts and shoes for balance test.

Group Type EXPERIMENTAL

Modified shoe inserts

Intervention Type DEVICE

For experimental arm: wear modified shoe inserts and shoes for balance test.

without modified shoe inserts

only wear the shoes for balance test.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Modified shoe inserts

For experimental arm: wear modified shoe inserts and shoes for balance test.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* preschool aged children with delayed motor development

Exclusion Criteria

1. lower limb injury case in six months.
2. other neurological history such as cerebral palsy, traumatic brain injury, spina bifida to cause of developmental delay.
3. have been or are receiving insoles correction or treatment.
4. can not be completed with the instruction by foot measurement and balance measurement.
Minimum Eligible Age

36 Months

Maximum Eligible Age

83 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chung Shan Medical University

OTHER

Sponsor Role lead

Responsible Party

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GCRC

Director, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kun-Chung Chen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

School of Physical Therapy, Chung Shan Medical University

Locations

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Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS15103

Identifier Type: -

Identifier Source: org_study_id