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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
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flatfoot, Flexible

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 11, 2022
    Last Updated
    September 8, 2022
    Sponsor
    Taipei Medical University WanFang Hospital
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    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

    Learn more about this trial

    The Effect of Insoles on Functional Performance in Pediatric Flexible Flatfoot

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