The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
Primary Purpose
Flatfoot, Flexible
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
arch insole and sham insole
Sponsored by
About this trial
This is an interventional treatment trial for Flatfoot, Flexible
Eligibility Criteria
Inclusion Criteria:
- Children presenting symptomatic flexible flatfoot only
Exclusion Criteria:
- Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
arch insole
sham insole
Arm Description
Half of the subjects are randomly assigned to assess balance capacity with arch insole first. Three day wash out, the subjects are assess balance capacity with sham insole.
Half of the subjects are randomly assigned to assess balance capacity with sham insole first. Three day wash out, the subjects are assess balance capacity with arch insole.
Outcomes
Primary Outcome Measures
Change in Functional Reach Test(FRT) from pre to post-intervention.
The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Pediatric Berg Balance Scale
Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.
Secondary Outcome Measures
Change in Center of pressure (CoP) from pre to post-intervention.
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system.
Full Information
NCT ID
NCT05533762
First Posted
August 11, 2022
Last Updated
September 8, 2022
Sponsor
Taipei Medical University WanFang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05533762
Brief Title
The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
Official Title
The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2022 (Anticipated)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Flexible flatfoot is a condition that increase the load of the foot structure.With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot.
Detailed Description
Flexible flatfoot is a condition that involves the collapse of the medial longitudinal arch of the foot during weight-bearing stress and the restoration of the arch after the removal of body weight.
Flatfoot may increase the load of the foot structure, potentially interfering with normal foot function. With prolonged standing or walking, some children with flatfoot experience rapid discomfort or fatigue in the foot, pain in the plantar foot, and instability of the medial foot structure. Treatment effect of corrective shoes or insoles on flexible flatfoot in children remain uncertain.
In this study, the investigators investigated the short-term effects of customized insoles on body functions and structures, and activities and participation in children with flexible flatfoot. The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
The investigators hypothesized that the short-term use of customized insoles improves the scores for measures of body functions and structures and activities and participation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot, Flexible
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
arch insole
Arm Type
Active Comparator
Arm Description
Half of the subjects are randomly assigned to assess balance capacity with arch insole first.
Three day wash out, the subjects are assess balance capacity with sham insole.
Arm Title
sham insole
Arm Type
Sham Comparator
Arm Description
Half of the subjects are randomly assigned to assess balance capacity with sham insole first.
Three day wash out, the subjects are assess balance capacity with arch insole.
Intervention Type
Device
Intervention Name(s)
arch insole and sham insole
Intervention Description
children wear insoles on feet
Primary Outcome Measure Information:
Title
Change in Functional Reach Test(FRT) from pre to post-intervention.
Description
The Functional Reach Test (FRT) is a quick screen for determining balance capacity.
Time Frame
up to 10 minutes
Title
Pediatric Berg Balance Scale
Description
Pediatric Berg Balance Scale was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
Maximum score is 56 ,and minimum values is 0. Score 54-56 means a better outcome.
Time Frame
up to 30 minutes
Secondary Outcome Measure Information:
Title
Change in Center of pressure (CoP) from pre to post-intervention.
Description
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of RSSCAN system.
Time Frame
up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children presenting symptomatic flexible flatfoot only
Exclusion Criteria:
Children with a history of foot injury or surgery, foot abnormalities or a confirmed diagnosis such as neurological deficits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YenTing LIU
Phone
+886-229307930
Ext
1612
Email
95175@w.tmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YenTing LIU, Master
Organizational Affiliation
Wang Fang Hospital, Taipei Medical University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot
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