Effects of Insoles on Children With Developmental Delays

Therapeutic Effects of Physical Function and Balance of Customized Insoles on Children With Developmental Delays

Using double blind, randomized controlled design to investigate the short-term therapeutic effects of function of customized insoles on children with developmental delays

Study Overview

• Status: Unknown
• Conditions: Developmental Delay
• Intervention / Treatment: Device: MEI BIN insoles

Detailed Description

A total of 52 children with developmental delays will be enrolled. The participants will be randomized into two groups, including study group (with insoles) and control group (without insoles).

The participants in the study group will be evaluated at baseline, that is before the customized insoles are prescribed. All of evaluations, including physical function, balance, and quality of life will be re-evaluated up to 12 weeks after insoles wearing.

The control group will be evaluated at the baseline and up to 12 weeks.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• developmental delays

Exclusion Criteria:

• age less than 3 years old or older than 10 years old normal development

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group: MEI BIN insoles; Participants 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.	Device: MEI BIN insoles; insoles
No Intervention: control group: without MEI BIN insoles; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline functional performance (scores) at 12 weeks	Pediatric Outcome Data Collection Instrument	baseline and up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline physical function (time) at 12 weeks	time of stair climbing, timed up and go, walking on level ground	baseline and up to 12 weeks
change from baseline balance (scores) at 12 weeks	Berg balance scale	baseline and up to 12 weeks
change from baseline quality of life at 12 weeks	Pediatric Quality of Life inventory (PedsQL)	baseline and up to 12 weeks

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Collaborators: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Principal Investigator: Ru-Lan Hsieh, MD, Shin Kong Wu Ho-Su Memorial Hospital; Taipei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 24, 2017
• Primary Completion (Anticipated): December 31, 2017
• Study Completion (Anticipated): December 31, 2017

Study Registration Dates

• First Submitted: June 11, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 19, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: children; effect; insoles
• Other Study ID Numbers: SKH-8302-106-DR-28.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No