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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:

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.

Sponsor: Wilfrid Laurier University

Current Primary Outcome:

• 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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Wilfrid Laurier University

Dates:
Date Received: November 2, 2016
Date Started: November 2016
Date Completion: August 2017
Last Updated: January 16, 2017
Last Verified: January 2017