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The Balance Influence of Shoe Inserts on Motor Development Delayed Children

Chung Shan Medical University Hospital Institutional Review Board

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02644317
Enrollment
100
Registered
2015-12-31
Start date
2015-12-31
Completion date
2018-12-31
Last updated
2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development Delay

Keywords

Motor development delay, balance, flatfoot, shoe insert

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.

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.

Interventions

DEVICEModified shoe inserts

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

Sponsors

Chung Shan Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
36 Months to 83 Months
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.

Design outcomes

Primary

MeasureTime frameDescription
The balance change of Movement ABC-2 scalesbaseline/immediately/12 weeks/1 year/2 yearbalance subscore of Movement ABC-2 scales

Secondary

MeasureTime frameDescription
The change of foot print parametersbaseline/12 weeks/1 year/2 yearfoot-print parameters(using CSI scales)

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026