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Completed

NCT Number: NCT02957812

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 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.

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Key information

Conditions

Flatfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Biomechanics Lab

Waterloo, Ontario, N2L 3C5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Custom-made Foot Orthotics (CFO)

Device

Provides longitudinal arch support

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Wilfrid Laurier University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 8, 2016
Registry last updated
Mar 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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