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

Flatfoot Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02957812
• Other study ID #: 5114
• Status: Completed
• Phase: N/A
• First received: November 2, 2016
• Last updated: February 27, 2018
• Start date: November 2016
• Est. completion date: August 31, 2017

Study information

• Verified date: February 2018
• Source: Wilfrid Laurier University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 31, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Flatfoot

Intervention

Device:
• Custom-made Foot Orthotics (CFO)
Provides longitudinal arch support

Locations

Country	Name	City	State
Canada	Biomechanics Lab	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Wilfrid Laurier University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	change in muscle activity and timing of Electromyography (EMG)	muscle activity and muscle timing	Baseline, 6 weeks, and 12 weeks
Primary	change in Balance stability margin	how close their body gets to perimeter of their base of support	Baseline, 6 weeks, and 12 weeks
Secondary	Range of motion (ROM)	the degrees of motion that occurs at the joint	Baseline and 12 weeks
Secondary	Stride Length	the distance between heel strike of the same limb	Baseline and 12 weeks
Secondary	Stride Width	the lateral distance between midlines of each foot	Baseline and 12 weeks
Secondary	Gait Velocity	The rate of change in position with respect to time	Baseline and 12 weeks