The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination
Primary Purpose
Flatfoot
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Custom-made Foot Orthotics (CFO)
Sponsored by
About this trial
This is an interventional supportive care trial for Flatfoot focused on measuring Gait, Balance Control, Orthotics
Eligibility Criteria
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.
Sites / Locations
- Biomechanics Lab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Orthotics
Control
Arm Description
Custom made orthotic provided for study
Wearing own footwear
Outcomes
Primary Outcome Measures
Change in Cross-sectional area (CSA) of intrinsic foot muscles
the area of the cross section of a muscle perpendicular to its fibers
change in muscle activity and timing of Electromyography (EMG)
muscle activity and muscle timing
change in Balance stability margin
how close their body gets to perimeter of their base of support
Secondary Outcome Measures
Range of motion (ROM)
the degrees of motion that occurs at the joint
Stride Length
the distance between heel strike of the same limb
Stride Width
the lateral distance between midlines of each foot
Gait Velocity
The rate of change in position with respect to time
Full Information
NCT ID
NCT02957812
First Posted
November 2, 2016
Last Updated
February 27, 2018
Sponsor
Wilfrid Laurier University
1. Study Identification
Unique Protocol Identification Number
NCT02957812
Brief Title
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 Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 21, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wilfrid Laurier University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot
Keywords
Gait, Balance Control, Orthotics
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Orthotics
Arm Type
Experimental
Arm Description
Custom made orthotic provided for study
Arm Title
Control
Arm Type
No Intervention
Arm Description
Wearing own footwear
Intervention Type
Device
Intervention Name(s)
Custom-made Foot Orthotics (CFO)
Intervention Description
Provides longitudinal arch support
Primary Outcome Measure Information:
Title
Change in Cross-sectional area (CSA) of intrinsic foot muscles
Description
the area of the cross section of a muscle perpendicular to its fibers
Time Frame
Baseline, 6 weeks, and 12 weeks post baseline
Title
change in muscle activity and timing of Electromyography (EMG)
Description
muscle activity and muscle timing
Time Frame
Baseline, 6 weeks, and 12 weeks
Title
change in Balance stability margin
Description
how close their body gets to perimeter of their base of support
Time Frame
Baseline, 6 weeks, and 12 weeks
Secondary Outcome Measure Information:
Title
Range of motion (ROM)
Description
the degrees of motion that occurs at the joint
Time Frame
Baseline and 12 weeks
Title
Stride Length
Description
the distance between heel strike of the same limb
Time Frame
Baseline and 12 weeks
Title
Stride Width
Description
the lateral distance between midlines of each foot
Time Frame
Baseline and 12 weeks
Title
Gait Velocity
Description
The rate of change in position with respect to time
Time Frame
Baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Biomechanics Lab
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3C5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this 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
We'll reach out to this number within 24 hrs