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The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02957812
Recruitment Status : Completed
First Posted : November 8, 2016
Last Update Posted : March 1, 2018
Information provided by (Responsible Party):
Katrina Protopapas, Wilfrid Laurier University

Brief Summary:
The purpose of this study is to explore the long-term effects that orthotics imposes on the structure and function of the foot. The objectives of the study are to determine if the use of custom-made foot orthotics (CFO) cause: (a) changes to the structure of the plantar intrinsic muscles, (b) changes in the rate of muscle activity and timing in the plantar intrinsic muscles and (c) creates any changes in balance control during gait termination. The aim of the study is to enhance the appropriate dispensing of orthotics, and whether additional measures, such as rehabilitation exercises are necessary to increase their overall effectiveness in the clinical setting.

Condition or disease Intervention/treatment Phase
Flatfoot Device: Custom-made Foot Orthotics (CFO) Not Applicable

Detailed Description:

Between 20-30 healthy young adults of both males and females will be recruited. A screening questionnaire will be administered to ensure that participants are appropriate for the study.

Once the participant has met the criteria of the study, the participants will be randomly allocated into one of two groups: (a) the control group or (b) the intervention group. Individuals that are selected to be in the intervention group, will be fitted with custom-made orthotics by an experienced pedorthist. The pedorthist will cast the foot posture using a foam impression to custom the design of the foot orthotic. The participant will have a week to acclimatize to the new environment, and if any discomfort arises the pedorthist will make any necessary corrections and the participant will have another week to acclimatize to the orthotic. The control group will not receive an intervention and ask to go about their daily life activities. All participants will undergo the same testing procedures at 6 and 12 weeks after baseline testing.

At baseline, 6 weeks and 12 weeks post-baseline, the researcher will take a diagnostic ultrasound image of the foot muscles prior to the gait trials. The researcher will also place 12 infrared markers and surface electrodes on the participant. All trials will be performed barefoot. The participants will then undergo a gait termination protocol. Participants will walk down an 8m walk-way with three force plates are embedded into the ground. Participants will be asked to walk to the end of the platform until instructed to stop. For 20% of the gait trials, the participants are walking forward until they hear an audio buzzer sound that will signal them to terminate their gait suddenly in the next two steps. All trials will be randomized.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : November 2016
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Orthotics
Custom made orthotic provided for study
Device: Custom-made Foot Orthotics (CFO)
Provides longitudinal arch support

No Intervention: Control
Wearing own footwear

Primary Outcome Measures :
  1. Change in Cross-sectional area (CSA) of intrinsic foot muscles [ Time Frame: Baseline, 6 weeks, and 12 weeks post baseline ]
    the area of the cross section of a muscle perpendicular to its fibers

  2. change in muscle activity and timing of Electromyography (EMG) [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    muscle activity and muscle timing

  3. change in Balance stability margin [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
    how close their body gets to perimeter of their base of support

Secondary Outcome Measures :
  1. Range of motion (ROM) [ Time Frame: Baseline and 12 weeks ]
    the degrees of motion that occurs at the joint

  2. Stride Length [ Time Frame: Baseline and 12 weeks ]
    the distance between heel strike of the same limb

  3. Stride Width [ Time Frame: Baseline and 12 weeks ]
    the lateral distance between midlines of each foot

  4. Gait Velocity [ Time Frame: Baseline and 12 weeks ]
    The rate of change in position with respect to time

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • a score of (+5) on the Foot Posture Index (FPI)
  • navicular height < 3.6cm
  • able to walk

Exclusion Criteria:

  • have worn CFOs in the past year,
  • current lower limb injury, leg or foot pain
  • neurological or musculoskeletal disorders affecting the function of the foot
  • previous history of lower limb surgery
  • protein intake above the recommended daily allowance (RDA)
  • medications that effect balance.

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 identifier (NCT number): NCT02957812

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Canada, Ontario
Biomechanics Lab
Waterloo, Ontario, Canada, N2L 3C5
Sponsors and Collaborators
Wilfrid Laurier University
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Responsible Party: Katrina Protopapas, Principal Investigator, Wilfrid Laurier University Identifier: NCT02957812    
Other Study ID Numbers: 5114
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Katrina Protopapas, Wilfrid Laurier University:
Balance Control
Additional relevant MeSH terms:
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Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities