The Balance Influence of Shoe Inserts on Motor Development Delayed Children

December 30, 2015 updated by: GCRC, Chung Shan Medical University

Chung Shan Medical University Hospital Institutional Review Board

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with modified shoe inserts
wear the modified shoe inserts and shoes for balance test.
Device: Modified shoe inserts
For experimental arm: wear modified shoe inserts and shoes for balance test.
No Intervention: without modified shoe inserts
only wear the shoes for balance test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The balance change of Movement ABC-2 scales
Time Frame: baseline/immediately/12 weeks/1 year/2 year
balance subscore of Movement ABC-2 scales
baseline/immediately/12 weeks/1 year/2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of foot print parameters
Time Frame: baseline/12 weeks/1 year/2 year
foot-print parameters(using CSI scales)
baseline/12 weeks/1 year/2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Principal Investigator: Kun-Chung Chen, Ph.D., School of Physical Therapy, Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS15103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Development Delay

Clinical Trials on Modified shoe inserts

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe