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.

Study Overview

• Status: Completed
• Conditions: Flatfoot
• Intervention / Treatment: Device: Custom-made Foot Orthotics (CFO)

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3C5
      • Biomechanics lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cross-sectional area (CSA) of intrinsic foot muscles	the area of the cross section of a muscle perpendicular to its fibers	Baseline, 6 weeks, and 12 weeks post baseline
change in muscle activity and timing of Electromyography (EMG)	muscle activity and muscle timing	Baseline, 6 weeks, and 12 weeks
change in Balance stability margin	how close their body gets to perimeter of their base of support	Baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)	the degrees of motion that occurs at the joint	Baseline and 12 weeks
Stride Length	the distance between heel strike of the same limb	Baseline and 12 weeks
Stride Width	the lateral distance between midlines of each foot	Baseline and 12 weeks
Gait Velocity	The rate of change in position with respect to time	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Wilfrid Laurier University

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 3, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 27, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Gait; Orthotics; Balance Control
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: 5114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided