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Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

Primary Purpose

Flexible Flatfoot

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
foot insole
short foot exercise
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexible Flatfoot focused on measuring Flatfoot, Insole, Short-foot exercise, Orthotic

Eligibility Criteria

18 Years - 36 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Females and males aged between 18 and 36
  • Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower limb fatigue
  • Participants must show positive physical examination findings, including a positive result for the "too many toes" sign, the navicular drop test, and the foot toe raising test (Carr et al., 2016). A positive result for the "too many toes" sign occurs when more toes can be seen on the lateral side of each foot due to external rotation and abduction of the feet, and the positive result for the toe rising test is the reconstruction of the medial longitudinal arch secondary to the tightness of the plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017)

Exclusion Criteria:

  • An anatomical discrepancy in leg length
  • Pathologic or neurologic disorders of the feet
  • A history of traumatic foot injury or surgery within the last six months
  • History of wearing foot orthoses within the past two years

Sites / Locations

  • Imam Abdulrahman Bin Faisal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

insole group

exercise group

Arm Description

the control group receives insole only.

the experimental group receives exercise and insole.

Outcomes

Primary Outcome Measures

The EMED (force-area-pressure)
The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.

Secondary Outcome Measures

Lower extremities functional scale, navicular drop test
The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.

Full Information

First Posted
July 2, 2020
Last Updated
July 16, 2020
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT04480177
Brief Title
Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects
Official Title
Effect of Intrinsic Foot Muscles Training and Foot Orthosis on the Medial Longitudinal Arch in Flexible Flatfoot Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 27, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal 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
Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot. The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.
Detailed Description
Study design: A parallel, active-control study design was used to conduct a single-blinded randomized controlled trial. Method: The toe rising test, the "too many toes" sign, and the navicular drop test was used to select 30 participants with flexible flatfoot. Participants was randomly assigned either to an experimental group (n = 15) or a control group (n = 15). The experimental group received short foot exercises (SFE) and insoles, and the control group received only insoles. SFE was implemented 30 times for a duration of three minutes each day over the course of six weeks. The exercise progressed from sitting to standing and finally to one leg stance position within every two weeks. The participants wore shoes containing orthotic insoles for eight hours per day for six weeks. The EMED-x system was used to measure plantar pressure distribution (force, area, and pressure) at baseline and at two-week intervals throughout the six-week intervention. The Lower Extremity Functional Scale (LEFS) was used to evaluate restriction in participants' functional abilities, and the navicular drop test (NDT) was used to assess the medial longitudinal arch (MLA) height. Both variables were measured at baseline and at the sixth week. Statistics: Mixed-effects ANOVA was used to test for significant interactions between the two groups across time and within-subject observations of the outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexible Flatfoot
Keywords
Flatfoot, Insole, Short-foot exercise, Orthotic

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
insole group
Arm Type
Other
Arm Description
the control group receives insole only.
Arm Title
exercise group
Arm Type
Experimental
Arm Description
the experimental group receives exercise and insole.
Intervention Type
Device
Intervention Name(s)
foot insole
Intervention Description
the subject was instructed to wear foot insole for 8 hours.
Intervention Type
Other
Intervention Name(s)
short foot exercise
Intervention Description
the subject was instructed to perform exercise once a day 30 repetitions.
Primary Outcome Measure Information:
Title
The EMED (force-area-pressure)
Description
The feet plantar pressure was measured at baseline and at two-week intervals throughout the six-week intervention.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Lower extremities functional scale, navicular drop test
Description
The Lower extremities functional scale was used to evaluate restriction in participants' functional abilities, The score ranges from 0 to 80, and if it is higher indicating less functional restrictions. The navicular drop test was used to assess the medial longitudinal arch (MLA) height, A positive result for the navicular drop test is an arch height more than or equal to 10 mm. Both variables were measured at baseline and at the sixth week.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females and males aged between 18 and 36 Bilateral symptomatic flexible flatfoot, with symptoms including foot pain and lower limb fatigue Participants must show positive physical examination findings, including a positive result for the "too many toes" sign, the navicular drop test, and the foot toe raising test (Carr et al., 2016). A positive result for the "too many toes" sign occurs when more toes can be seen on the lateral side of each foot due to external rotation and abduction of the feet, and the positive result for the toe rising test is the reconstruction of the medial longitudinal arch secondary to the tightness of the plantar fascia (Carr et al., 2016). A positive result for the navicular drop test is an arch height more than or equal to 10 mm(Aenumulapalli et al., 2017) Exclusion Criteria: An anatomical discrepancy in leg length Pathologic or neurologic disorders of the feet A history of traumatic foot injury or surgery within the last six months History of wearing foot orthoses within the past two years
Facility Information:
Facility Name
Imam Abdulrahman Bin Faisal University
City
Dammam
State/Province
Eastren
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

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