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OpenTrials
Completed

NCT Number: NCT03198299

Therapeutic Effects of Arch Support Insoles on Children

Using double blind, randomized controlled design to study the short-term therapeutic effects of customized arch support insoles on children

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Key information

Conditions

Normal Development

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

About this study

A total of 45 children were enrolled. The children were randomized into two groups, including the study group (insoles group) and the control group (without insoles group).

All participants in the insoles group were evaluated at baseline, that was before the customized arch-support insoles were prescribed. All the evaluations, including functional performance, physical function, and quality of life, were re-evaluated up to 12 weeks after the insoles wearing in the study group (insoles group).

The control group were evaluated at baseline and up to 12 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children with age 3 to 10 can walk independently for 15 meters can follow up for 12 weeks

Exclusion criteria

  • age less than 3 years or older than 10 years children with developmental delays children with pathological flat feet

Treatment and study plan

MEI BIN insoles

Device

wearing insoles for 12 weeks

Primary outcomes

  1. change of baseline of level walking time to 12 weeks

    Time frame: baseline and up to 12 weeks

    time of level walking

  2. change of baseline of stairs climbing time to 12 weeks

    Time frame: baseline and up to 12 weeks

    time of stairs climbing

  3. change of baseline of up and go time to 12 weeks

    Time frame: baseline and up to 12 weeks

    time of up and go

  4. change of baseline of chair raising time to 12 weeks

    Time frame: baseline and up to 12 week

    time of chair raising

Secondary outcomes

  1. change of baseline balance (scores) to 12 weeks

    Time frame: baseline and up to 12 weeks

    Berg balance test

  2. change of baseline functional performance(scores) to 12 weeks

    Time frame: baseline and up to 12 weeks

    Pediatric Outcome Data Collection instrument

  3. change of baseline quality of life (scores) to 12 weeks

    Time frame: baseline and up to 12 weeks

    Child Health Questionnaire-Parent form

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 26, 2017
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.