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Therapeutic Effects of Arch Support Insoles on 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.
 
ClinicalTrials.gov Identifier: NCT03198299
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Ru-Lan Hsieh, Taipei Medical University

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

Condition or disease Intervention/treatment Phase
Normal Development Device: MEI BIN insoles Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Therapeutic Effects of Physical Function and Balance of Arch Support Insoles on Children
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Arm Intervention/treatment
Active Comparator: study group: MEI BIN insoles
Study group: participants in the study group were prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.
Device: MEI BIN insoles
wearing insoles for 12 weeks

No Intervention: control group: without MEI BIN insoles
Control group: participants in the control group were not prescribed with customized insoles (MEI BIN insoles) to keep the subtalar joint in neutral position, for 12 weeks.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03198299


Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111-01
Sponsors and Collaborators
Taipei Medical University
Investigators
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Principal Investigator: Ru-Lan Hsieh Shin Kong Wu Ho-Su Memorial Hospital

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Responsible Party: Ru-Lan Hsieh, primary investigator, Taipei Medical University
ClinicalTrials.gov Identifier: NCT03198299    
Other Study ID Numbers: SKH-8302-105-DR-24
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ru-Lan Hsieh, Taipei Medical University:
therapeutic effects
insoles
children