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Comparison of Two Different Insole Types in Painful Flexible Flatfoot

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ClinicalTrials.gov Identifier: NCT02706327
Recruitment Status : Completed
First Posted : March 11, 2016
Results First Posted : July 14, 2017
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Hacettepe University
Information provided by (Responsible Party):
Yasin YURT, Eastern Mediterranean University

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.

Condition or disease Intervention/treatment Phase
Flatfoot Device: CAD/CAM Insole Device: Semi-custom Insole Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: CAD/CAM
8-week follow-up with CAD/CAM insole and home based exercise program
Device: CAD/CAM Insole
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.

Experimental: Semi-custom
8-week follow-up with semi-custom insole and home based exercise program
Device: Semi-custom Insole
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.

Placebo Comparator: Control
8-week follow-up with placebo insole and home based exercise program
Other: Control
15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.




Primary Outcome Measures :
  1. Change in Pain Intensity Measured by 100 mm Visual Analog Scale [ Time Frame: Baseline and week 8 ]

    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 :
  1. Change in Quality of Life Assessed With Short Form-36 Scale [ Time Frame: Baseline and week 8 ]

    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.



Other Outcome Measures:
  1. Balance Was Assessed With a Dynamic Platform [ Time Frame: In the same session after 8 weeks ]

    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.


  2. Six-minute Walk Physiological Cost Index Was Calculated [ Time Frame: In the same session after 8 weeks ]

    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.


  3. Vertical Jump Height Was Measured With a Special Mat [ Time Frame: In the same session after 8 weeks ]

    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.




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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02706327


Sponsors and Collaborators
Eastern Mediterranean University
Hacettepe University
Investigators
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Principal Investigator: Yasin Yurt, Dr. Eastern Mediterranean University

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Responsible Party: Yasin YURT, Assist. Prof. Dr., Eastern Mediterranean University
ClinicalTrials.gov Identifier: NCT02706327     History of Changes
Other Study ID Numbers: GO 14/18-31
First Posted: March 11, 2016    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yasin YURT, Eastern Mediterranean University:
orthotic insoles
pain
quality of life
athletic performance
Additional relevant MeSH terms:
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Flatfoot
Talipes
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities