The Balance Influence of Shoe Inserts on Motor Development Delayed Children

Development Delay Clinical Trial

Official title:

Chung Shan Medical University Hospital Institutional Review Board

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02644317
• Other study ID #: CS15103
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 30, 2015
• Last updated: December 30, 2015
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Chung Shan Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Months to 83 Months

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Development Delay

Intervention

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

Locations

Country	Name	City	State
Taiwan	Chung Shan Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Chung Shan Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The balance change of Movement ABC-2 scales	balance subscore of Movement ABC-2 scales	baseline/immediately/12 weeks/1 year/2 year	Yes
Secondary	The change of foot print parameters	foot-print parameters(using CSI scales)	baseline/12 weeks/1 year/2 year	Yes