The Balance Influence of Shoe Inserts on Motor Development Delayed Children

Sponsor

Chung Shan Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02644317

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Development Delay	Device: Modified shoe inserts	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Chung Shan Medical University Hospital Institutional Review Board

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The balance change of Movement ABC-2 scales [baseline/immediately/12 weeks/1 year/2 year]
balance subscore of Movement ABC-2 scales

Secondary Outcome Measures

The change of foot print parameters [baseline/12 weeks/1 year/2 year]
foot-print parameters(using CSI scales)

Eligibility Criteria

Criteria

Ages Eligible for Study:

36 Months to 83 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

preschool aged children with delayed motor development

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung Shan Medical University Hospital	Taichung		Taiwan	40201

Sponsors and Collaborators

Chung Shan Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCRC, Director, Clinical Research, Chung Shan Medical University

ClinicalTrials.gov Identifier:

NCT02644317

Other Study ID Numbers:

CS15103

First Posted:

Dec 31, 2015

Last Update Posted:

Dec 31, 2015

Last Verified:

Dec 1, 2015

Keywords provided by GCRC, Director, Clinical Research, Chung Shan Medical University

Motor development delay

balance

flatfoot

shoe insert

Study Results

No Results Posted as of Dec 31, 2015