An interventional study of Custom-made Foot Orthotics (CFO) in Flatfoot, sponsored by Wilfrid Laurier University. Completed at 1 site in Canada. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-01.
Sponsored by Wilfrid Laurier University · Not applicable, Interventional, and Supportive care
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.
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.
168 studies on the registry are indexed under Flatfoot; 41 are open to participants now.
This study's enrollment of 18 is below the median of 37 across 121 interventional studies indexed under Flatfoot.
Browse Flatfoot studies →Wilfrid Laurier University is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Custom made orthotic provided for study
Device: Custom-made Foot Orthotics (CFO)
Wearing own footwear
Provides longitudinal arch support
Change in Cross-sectional area (CSA) of intrinsic foot muscles
the area of the cross section of a muscle perpendicular to its fibers
Time frame: Baseline, 6 weeks, and 12 weeks post baseline
change in muscle activity and timing of Electromyography (EMG)
muscle activity and muscle timing
Time frame: Baseline, 6 weeks, and 12 weeks
change in Balance stability margin
how close their body gets to perimeter of their base of support
Time frame: Baseline, 6 weeks, and 12 weeks
Range of motion (ROM)
the degrees of motion that occurs at the joint
Time frame: Baseline and 12 weeks
Stride Length
the distance between heel strike of the same limb
Time frame: Baseline and 12 weeks
Stride Width
the lateral distance between midlines of each foot
Time frame: Baseline and 12 weeks
Gait Velocity
The rate of change in position with respect to time
Time frame: Baseline and 12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Wilfrid Laurier University