FlatfootNCT02957812
The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination
A study testing Custom-made Foot Orthotics (CFO) in people with Flatfoot, run by Wilfrid Laurier University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Flatfoot
- What is being tested?
- Custom-made Foot Orthotics (CFO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a score of (+5) on the Foot Posture Index (FPI)
- navicular height < 3.6cm
- able to walk
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Flatfoot
- Being tested
- Custom-made Foot Orthotics (CFO)
- Keywords
- Gait, Balance Control, Orthotics
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-made Foot Orthotics (CFO)Device
Provides longitudinal arch support
| Study group | Role | What they receive |
|---|---|---|
| Orthotics | Experimental | Custom made orthotic provided for study Receives: Device: Custom-made Foot Orthotics (CFO) |
| Control | No intervention | Wearing own footwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cross-sectional area (CSA) of intrinsic foot muscles
the area of the cross section of a muscle perpendicular to its fibers
Measured: Baseline, 6 weeks, and 12 weeks post baseline
change in muscle activity and timing of Electromyography (EMG)
muscle activity and muscle timing
Measured: Baseline, 6 weeks, and 12 weeks
change in Balance stability margin
how close their body gets to perimeter of their base of support
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (4)
Range of motion (ROM)
the degrees of motion that occurs at the joint
Measured: Baseline and 12 weeks
Stride Length
the distance between heel strike of the same limb
Measured: Baseline and 12 weeks
Stride Width
the lateral distance between midlines of each foot
Measured: Baseline and 12 weeks
Gait Velocity
The rate of change in position with respect to time
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion21 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilfrid Laurier University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrina Protopapas, Wilfrid Laurier University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957812
- Sponsor's protocol ID
- 5114
- Status last verified
- Feb 2018
- First submitted
- 2 Nov 2016
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02957812
- Acronym / sponsor ID
- 5114
- Conditions
- Flatfoot
- Keywords
- Gait, Balance Control, Orthotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Wilfrid Laurier UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 21 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthotics | Experimental | Device: Custom-made Foot Orthotics (CFO)Custom made orthotic provided for study |
| Control | No intervention | –Wearing own footwear |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a score of (+5) on the Foot Posture Index (FPI)
- navicular height < 3.6cm
- able to walk
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Custom-made Foot Orthotics (CFO)Provides longitudinal arch support | Device | Orthotics |
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
4 secondary outcomes
Range of motion (ROM)
Time frame: Baseline and 12 weeks
Stride Length
Time frame: Baseline and 12 weeks
Stride Width
Time frame: Baseline and 12 weeks
Gait Velocity
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-made Foot Orthotics (CFO) in people with Flatfoot, run by Wilfrid Laurier University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cross-sectional area (CSA) of intrinsic foot muscles (time frame: Baseline, 6 weeks, and 12 weeks post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.