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Clinical Trials/NCT02957812
NCT02957812
Completed
N/A

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

Wilfrid Laurier University1 site in 1 country18 target enrollmentNovember 2016
ConditionsFlatfoot

Overview

Phase
N/A
Intervention
Not specified
Conditions
Flatfoot
Sponsor
Wilfrid Laurier University
Enrollment
18
Locations
1
Primary Endpoint
Change in Cross-sectional area (CSA) of intrinsic foot muscles
Status
Completed
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
August 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katrina Protopapas

Principal Investigator

Wilfrid Laurier University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

change in muscle activity and timing of Electromyography (EMG)

Time Frame: Baseline, 6 weeks, and 12 weeks

muscle activity and muscle timing

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

  • Stride Length(Baseline and 12 weeks)
  • Range of motion (ROM)(Baseline and 12 weeks)
  • Stride Width(Baseline and 12 weeks)
  • Gait Velocity(Baseline and 12 weeks)

Study Sites (1)

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