NCT03198299

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1 year

First QC Date

June 13, 2017

Last Update Submit

June 22, 2017

Conditions

Normal Development

Keywords

therapeutic effectsinsoleschildren

Outcome Measures

Primary Outcomes (4)

  • change of baseline of level walking time to 12 weeks

    time of level walking

    baseline and up to 12 weeks

  • change of baseline of stairs climbing time to 12 weeks

    time of stairs climbing

    baseline and up to 12 weeks

  • change of baseline of up and go time to 12 weeks

    time of up and go

    baseline and up to 12 weeks

  • change of baseline of chair raising time to 12 weeks

    time of chair raising

    baseline and up to 12 week

Secondary Outcomes (3)

  • change of baseline balance (scores) to 12 weeks

    baseline and up to 12 weeks

  • change of baseline functional performance(scores) to 12 weeks

    baseline and up to 12 weeks

  • change of baseline quality of life (scores) to 12 weeks

    baseline and up to 12 weeks

Study Arms (2)

study group: MEI BIN insoles

ACTIVE COMPARATOR

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

control group: without MEI BIN insoles

NO INTERVENTION

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.

Interventions

MEI BIN insolesDEVICE

wearing insoles for 12 weeks

study group: MEI BIN insoles

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

Study Officials

  • Ru-Lan Hsieh

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
primary investigator

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 26, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)