Back to resultsInvestigation of the Effect of Specially Designed Insoles for Flat-footed Patients
Primary Purpose
Flat Foot [Pes Planus] (Acquired), Unspecified Foot
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ICB Medical Insoles
ICM Insoles
Sponsored by
About this trial
This is an interventional treatment trial for Flat Foot [Pes Planus] (Acquired), Unspecified Foot
Eligibility Criteria
Inclusion Criteria:
- 1. Having a minimum 5 degree subtalar pronation angle while standing,
- 2. A minimum score of +6 from the Foot Posture Index (API) scale
- 3. Being between the ages of 18-45
- 4. Not having received any treatment from the foot area in the last 6 months
- 5. To have cognitive competence
Exclusion Criteria:
- 1. End of volunteering
- 2. Having a history of surgery of the lower extremity
- 3. Being an active athlete
- 4. Being pregnant or diagnosed with malignancy
- 5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
- 6. Lower extremity inequality greater than 1 centimeter (cm)
- 7. Having a different orthopedic disease that may affect lower extremity biomechanics
- 8. Receiving a different treatment for pes planus
Sites / Locations
- Abant Izzet Baysal University Faculty of Health Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
ICB Special Insoles
ICB Insoles
Outcomes
Primary Outcome Measures
The Physical Activity Assessment Questionnaire (IPAQ) Short Form
This form will be used to measure physical activity levels. comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. Higher scores indicates better physical activity level.
Flamingo Balance Test and Y Balance Test
This will be applied for balance evaluation.To assess the ability to balance successfully on a single leg. A stopwatch, metal beam 50cm long, 5cm high and 3cm wide needed for test procedure. The total number of falls or loss of balance in 60 seconds is recorded. Scoring tables are available in the Eurofit Manual.
Secondary Outcome Measures
Standing Long Jump Test
For functional performance Standing Long Jump test will be applied.The athlete stands behind a line marked on the ground with feet slightly apart. A two foot take¬off and landing is used, with swinging of the arms and bending of the knees to provide forward drive. The subject attempts to jump as far as possible, landing on both feet without falling backwards. Three attempts are allowed. The measurement is taken from take¬off line to the nearest point of contact on the landing (back of the heels). Record the longest distance jumped, the best of three attempts. The table below gives a rating scale for the standing long jump test for adults, based on personal experiences.
10 Meter Walk Test
For functional performance10 Meter Walk test will be applied. Patient's will be asked to walk 10 meter. Time is measured while patients walk.
Shuttle Running Test
For functional performance Shuttle Running Test will be applied. his test requires the person to run back and forth between two parallel lines as fast as possible. Set up two lines of cones 30 feet apart or use line markings, and place two blocks of wood or a similar object behind one of the lines.Two or more trails may be performed, and the quickest time is recorded. Results are recorded to the nearest tenth of a second.
Full Information
NCT ID
NCT05306886
First Posted
March 24, 2022
Last Updated
August 30, 2023
Sponsor
Abant Izzet Baysal University
1. Study Identification
Unique Protocol Identification Number
NCT05306886
Brief Title
Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
Official Title
Investigation of the Effect of Specially Designed and 3D Printed Insoles on Physical Activity Levels, Balance and Functional Performances
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 16, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.
Detailed Description
Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics.
Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.
Patients will be randomized according to the order of their arrival at the clinic.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flat Foot [Pes Planus] (Acquired), Unspecified Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
ICB Special Insoles
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
ICB Insoles
Intervention Type
Other
Intervention Name(s)
ICB Medical Insoles
Intervention Description
After the foot analysis of the participants in the intervention group, special insoles will be designed in a computer program. In these insoles, 3-6 mm medial wedge support, 1-3 mm heel wedge support, 2-4 mm medial longitudinal arch support will be provided. These values will be determined according to the needs of each participant. A single physiotherapist will design all insoles. All drawings will be made by a single physiotherapist. After the design of the insoles is completed, insoles will be produced by transferring them to a Computer Numerical Control (CNC) machine. Ethyl vinyl acetate (EVA), the use of which has been found useful before, will be used as the material in the insoles molds. After processing, 1mm thick fabric will be used for the top coating. All insoles will be produced by the same physiotherapist.
Intervention Type
Other
Intervention Name(s)
ICM Insoles
Intervention Description
As in the intervention group, insoles will be designed for the participants in the control group, processed by CNC machine and the production will be completed. Only 2mm medial longitudinal arch support will be given to the insoles of the people in this group.
Primary Outcome Measure Information:
Title
The Physical Activity Assessment Questionnaire (IPAQ) Short Form
Description
This form will be used to measure physical activity levels. comprises a set of 4 questionnaires.
Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity. Higher scores indicates better physical activity level.
Time Frame
Eight weeks
Title
Flamingo Balance Test and Y Balance Test
Description
This will be applied for balance evaluation.To assess the ability to balance successfully on a single leg. A stopwatch, metal beam 50cm long, 5cm high and 3cm wide needed for test procedure. The total number of falls or loss of balance in 60 seconds is recorded. Scoring tables are available in the Eurofit Manual.
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Standing Long Jump Test
Description
For functional performance Standing Long Jump test will be applied.The athlete stands behind a line marked on the ground with feet slightly apart. A two foot take¬off and landing is used, with swinging of the arms and bending of the knees to provide forward drive. The subject attempts to jump as far as possible, landing on both feet without falling backwards. Three attempts are allowed. The measurement is taken from take¬off line to the nearest point of contact on the landing (back of the heels). Record the longest distance jumped, the best of three attempts. The table below gives a rating scale for the standing long jump test for adults, based on personal experiences.
Time Frame
Eight weeks
Title
10 Meter Walk Test
Description
For functional performance10 Meter Walk test will be applied. Patient's will be asked to walk 10 meter. Time is measured while patients walk.
Time Frame
Eight weeks
Title
Shuttle Running Test
Description
For functional performance Shuttle Running Test will be applied. his test requires the person to run back and forth between two parallel lines as fast as possible. Set up two lines of cones 30 feet apart or use line markings, and place two blocks of wood or a similar object behind one of the lines.Two or more trails may be performed, and the quickest time is recorded. Results are recorded to the nearest tenth of a second.
Time Frame
Eight 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:
1. Having a minimum 5 degree subtalar pronation angle while standing,
2. A minimum score of +6 from the Foot Posture Index (API) scale
3. Being between the ages of 18-45
4. Not having received any treatment from the foot area in the last 6 months
5. To have cognitive competence
Exclusion Criteria:
1. End of volunteering
2. Having a history of surgery of the lower extremity
3. Being an active athlete
4. Being pregnant or diagnosed with malignancy
5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
6. Lower extremity inequality greater than 1 centimeter (cm)
7. Having a different orthopedic disease that may affect lower extremity biomechanics
8. Receiving a different treatment for pes planus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramazan Kurul
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abant Izzet Baysal University Faculty of Health Science
City
Bolu
State/Province
Merkez
ZIP/Postal Code
14100
Country
Turkey
12. IPD Sharing Statement
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Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients
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