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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

Tracking Information
First Submitted Date  ICMJE March 3, 2016
First Posted Date  ICMJE March 11, 2016
Results First Submitted Date  ICMJE January 25, 2017
Results First Posted Date  ICMJE July 14, 2017
Last Update Posted Date November 1, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
Change in Pain Intensity Measured by 100 mm Visual Analog Scale [ Time Frame: Eight weeks ]
Change History Complete list of historical versions of study NCT02706327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2016)
Change in Quality of Life Assessed With Short Form-36 Scale [ Time Frame: Eight weeks ]
Current Other Pre-specified Outcome Measures
 (submitted: October 1, 2017)
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: March 7, 2016)
  • Balance Was Assessed With a Dynamic Platform [ Time Frame: At the end of eight weeks ]
    Dynamic platform (Technobody, Italy) was the equipment used in balance assessment. Measurements were taken with and without insoles in shoes.
  • Six-minute Walk Physiological Cost Index Was Calculated [ Time Frame: At the end of eight weeks ]
    Physiological cost index was calculated by taking heart rate with finger oximeter and walking distance after a six-minute walk test. Measurements were taken with and without insoles in shoes.
  • Vertical Jump Height Was Measured With a Special Mat [ Time Frame: At the end of eight weeks ]
    Sensor mat (NewTest, Powertimer, Finland) was used in vertical jump measurement. Measurements were taken with and without insoles in shoes.
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Different Insole Types in Painful Flexible Flatfoot
Official Title  ICMJE Comparison of Two Different Insole Types on Pain, Quality of Life and Physical Performance in Painful Flexible Flatfoot
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Flatfoot
Intervention  ICMJE
  • 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.
  • 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.
  • Other: Control
    15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
Study Arms  ICMJE
  • Experimental: CAD/CAM
    8-week follow-up with CAD/CAM insole and home based exercise program
    Intervention: Device: CAD/CAM Insole
  • Experimental: Semi-custom
    8-week follow-up with semi-custom insole and home based exercise program
    Intervention: Device: Semi-custom Insole
  • Placebo Comparator: Control
    8-week follow-up with placebo insole and home based exercise program
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2016)
67
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02706327
Other Study ID Numbers  ICMJE GO 14/18-31
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Yasin YURT, Eastern Mediterranean University
Study Sponsor  ICMJE Eastern Mediterranean University
Collaborators  ICMJE Hacettepe University
Investigators  ICMJE
Principal Investigator: Yasin Yurt, Dr. Eastern Mediterranean University
PRS Account Eastern Mediterranean University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP