Effects of Insoles on Children With Developmental Delays
Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays
1 other identifier
interventional
52
1 country
1
Brief Summary
Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedStudy Start
First participant enrolled
June 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedJune 26, 2017
June 1, 2017
6 months
June 11, 2017
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline functional performance (scores) at 12 weeks
Pediatric Outcome Data Collection Instrument
baseline and up to 12 weeks
Secondary Outcomes (3)
change from baseline physical function (time) at 12 weeks
baseline and up to 12 weeks
change from baseline balance (scores) at 12 weeks
baseline and up to 12 weeks
change from baseline quality of life at 12 weeks
baseline and up to 12 weeks
Study Arms (2)
study group: MEI BIN insoles
ACTIVE COMPARATORParticipants in the study group will be prescribed with a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.
control group: without MEI BIN insoles
NO INTERVENTIONParticipants in this control group will not receive a pair of customized insoles (MEI BIN) to keep the subtalar joint in neutral position, for 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- developmental delays
You may not qualify if:
- age less than 3 years old or older than 10 years old normal development
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taipei Medical Universitylead
- Shin Kong Wu Ho-Su Memorial Hospitalcollaborator
Study Sites (1)
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-01, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ru-Lan Hsieh, MD
Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University
Central Study Contacts
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
- Professor
Study Record Dates
First Submitted
June 11, 2017
First Posted
June 19, 2017
Study Start
June 24, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
June 26, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share