The Balance Influence of Shoe Inserts on Motor Development Delayed Children

NCT02644317 | Unknown

• 1 other identifier: CS15103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Development Delay

Keywords

Motor development delay; balance; flatfoot; shoe insert

Outcome Measures

Primary Outcomes (1)

• The balance change of Movement ABC-2 scales

  balance subscore of Movement ABC-2 scales

  baseline/immediately/12 weeks/1 year/2 year

Secondary Outcomes (1)

• The change of foot print parameters

  baseline/12 weeks/1 year/2 year

Study Arms (2)

with modified shoe inserts

EXPERIMENTAL

wear the modified shoe inserts and shoes for balance test.

Device: Modified shoe inserts

without modified shoe inserts

NO INTERVENTION

only wear the shoes for balance test.

Interventions

Modified shoe inserts DEVICE

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

with modified shoe inserts

Eligibility Criteria

• Age: 36 Months - 83 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preschool aged children with delayed motor development

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Learning Disabilities; Psychomotor Disorders; Flatfoot

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kun-Chung Chen, Ph.D.

  School of Physical Therapy, Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 31, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 31, 2015

Record last verified: 2015-12

Locations

TW (1)