The Balance Influence of Shoe Inserts on Motor Development Delayed Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02644317
Recruitment Status : Unknown
Verified December 2015 by GCRC, Chung Shan Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : December 31, 2015
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
GCRC, Chung Shan Medical University

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 Not Applicable

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  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The change of foot print parameters [ Time Frame: baseline/12 weeks/1 year/2 year ]
    foot-print parameters(using CSI scales)

Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 83 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02644317

Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Sponsors and Collaborators
Chung Shan Medical University
Principal Investigator: Kun-Chung Chen, Ph.D. School of Physical Therapy, Chung Shan Medical University

Responsible Party: GCRC, Director, Clinical Research, Chung Shan Medical University Identifier: NCT02644317     History of Changes
Other Study ID Numbers: CS15103
First Posted: December 31, 2015    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by GCRC, Chung Shan Medical University:
Motor development delay
shoe insert