The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination
Condition: Flatfoot
MeSH terms: Flatfoot
Study type: Interventional

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.
    

Intervention name(s): Custom-made Foot Orthotics (CFO)
Intervention type(s): Device
Intervention description(s): Provides longitudinal arch support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gait; Balance Control; Orthotics