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Comparison of Two Different Insole Types in Painful Flexible Flatfoot

Primary Purpose

Flatfoot

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CAD/CAM Insole
Semi-custom Insole
Control
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flatfoot focused on measuring orthotic insoles, pain, quality of life, athletic performance

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer),
  • minimum of + 6 points on the foot posture index,

Exclusion Criteria:

  • treatment of the foot for at least six months,
  • leg length discrepancy of more than 1 cm,
  • history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    CAD/CAM

    Semi-custom

    Control

    Arm Description

    8-week follow-up with CAD/CAM insole and home based exercise program

    8-week follow-up with semi-custom insole and home based exercise program

    8-week follow-up with placebo insole and home based exercise program

    Outcomes

    Primary Outcome Measures

    Change in Pain Intensity Measured by 100 mm Visual Analog Scale
    The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.

    Secondary Outcome Measures

    Change in Quality of Life Assessed With Short Form-36 Scale
    The scale scores the health related quality of life with 0 and 100, minimum and maximum levels. Each question is scored between 0-100 and the total score is found by dividing to number of question. Higher score or positive change mean better quality of life in the scale. We used physical health part of it. Changes were calculated as the difference between 8-week follow-up and baseline results.

    Full Information

    First Posted
    March 3, 2016
    Last Updated
    October 1, 2017
    Sponsor
    Eastern Mediterranean University
    Collaborators
    Hacettepe University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02706327
    Brief Title
    Comparison of Two Different Insole Types in Painful Flexible Flatfoot
    Official Title
    Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eastern Mediterranean University
    Collaborators
    Hacettepe University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare computer aided design/computer aided manufacturing (CAD/CAM) and semi-custom insole types on pain, quality of life and physical performance and also to decide whether they are necessary in treatment of painful flexible flatfoot.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flatfoot
    Keywords
    orthotic insoles, pain, quality of life, athletic performance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    67 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CAD/CAM
    Arm Type
    Experimental
    Arm Description
    8-week follow-up with CAD/CAM insole and home based exercise program
    Arm Title
    Semi-custom
    Arm Type
    Experimental
    Arm Description
    8-week follow-up with semi-custom insole and home based exercise program
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    8-week follow-up with placebo insole and home based exercise program
    Intervention Type
    Device
    Intervention Name(s)
    CAD/CAM Insole
    Intervention Description
    A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
    Intervention Type
    Device
    Intervention Name(s)
    Semi-custom Insole
    Intervention Description
    Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
    Primary Outcome Measure Information:
    Title
    Change in Pain Intensity Measured by 100 mm Visual Analog Scale
    Description
    The scale scores the pain intensity with 0 and 100 mm, minimum and maximum levels. Higher score means worse pain and also negative changes mean reduced pain. Participants were asked to rate the maximum level of foot pain they had in the last week. Changes were calculated as the difference between 8-week follow-up and baseline results.
    Time Frame
    Baseline and week 8
    Secondary Outcome Measure Information:
    Title
    Change in Quality of Life Assessed With Short Form-36 Scale
    Description
    The scale scores the health related quality of life with 0 and 100, minimum and maximum levels. Each question is scored between 0-100 and the total score is found by dividing to number of question. Higher score or positive change mean better quality of life in the scale. We used physical health part of it. Changes were calculated as the difference between 8-week follow-up and baseline results.
    Time Frame
    Baseline and week 8
    Other Pre-specified Outcome Measures:
    Title
    Balance Was Assessed With a Dynamic Platform
    Description
    Dynamic platform was the equipment used in balance assessment. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. The software calculates balance value between 0 and 5 that lower value means better balance score. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better balance score with insole.
    Time Frame
    In the same session after 8 weeks
    Title
    Six-minute Walk Physiological Cost Index Was Calculated
    Description
    Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test. The result is calculated by dividing one minute heart rate (beat) to walking distance (meter). Lower values mean better physiological cost. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, negative changes mean better score with insole.
    Time Frame
    In the same session after 8 weeks
    Title
    Vertical Jump Height Was Measured With a Special Mat
    Description
    Sensor mat was used in vertical jump measurement. The result is the distance (cm) that was jumped vertically and it is normalized by dividing the distance to length of subject in order to get percentage of jump distance. Higher values mean better vertical jump performance. Participants were assessed after using the insoles for 8 weeks in order to get compliance. Measurements were taken in the same day with and without insoles in shoes. Difference between with and without insole was calculated by subtracting the result with insole from the result without insole. Therefore, positive changes mean better score with insole.
    Time Frame
    In the same session after 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: minimum subtalar pronation of 5 degrees while standing (tibiocalcaneal angle, measured with goniometer), minimum of + 6 points on the foot posture index, Exclusion Criteria: treatment of the foot for at least six months, leg length discrepancy of more than 1 cm, history of lower extremity surgery, and no disease that could affect lower extremity biomechanics.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yasin Yurt, Dr.
    Organizational Affiliation
    Eastern Mediterranean University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Comparison of Two Different Insole Types in Painful Flexible Flatfoot

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