Foot Injuries and DisordersNCT04600102
SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
An observational study of Foot Injuries and Disorders, run by University of Iowa at 1 site in United States.
Trial summary
Orthotists currently use a range of weight bearing conditions when casting or scanning a patient's limb during the Ankle foot orthosis (AFO) fitting process. This variability in clinical practice is the result of differing opinions regarding the best method for fitting, and a limited understanding of how weight… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Foot Injuries and Disorders
- What is being tested?
- Structure Sensor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2020to May 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
GROUP 1
Patient Inclusion criteria
- Ages: 18-75
- Healthy individuals without a current complaint of lower extremity pain, spine pain, active infections or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- Ability to perform a full squat without pain
- Able to read and write in English and provide written informed consent
Patient Exclusion criteria
- Diagnosed moderate or severe brain injury
- Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Current complaint of pain or numbness in the spine
- Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
- Require an assistive device
- Open/unhealed wounds on lower extremity.
- Body mass index (BMI) above 35
GROUP 2
Patient Inclusion criteria
- Ages: 18-75
- Daily AFO use to address unilateral below knee functional deficits (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease)
- Ability to stand independently without use of an assistive device (Cane, crutch, etc)
- Ability to safely bear full body weight on affected limb without use of an AFO or other protection
- Able to read and write in English and provide written informed consent
Patient Exclusion criteria
- Use of an AFO that crosses the knee (includes Knee brace or similar)
- Open/unhealed wounds on lower extremity
- Uncorrected visual or hearing impairments that limit the ability to understand or comply with instructions given during testing
- Body mass index (BMI) above 35
- Diagnoses of a moderate to severe brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Orthotists currently use a range of weight bearing conditions when casting or scanning a patient's limb during the Ankle foot orthosis (AFO) fitting process. This variability in clinical practice is the result of differing opinions regarding the best method for fitting, and a limited understanding of how weight bearing affects the resulting geometry. Few studies have been performed to determine the effect of weight bearing on resulting geometry, or the consistency of the geometry obtained. In this study we seek to evaluate the effect of foot loading on lower limb geometry and the consistency of measurements using low-cost 3D scanning technology, with implications for fitting AFOs.
Read the detailed description
Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
We will obtain a brief medical history to identify major medical conditions or prior injuries that could influence limb geometry and lead to reliance on an AFO for Group 2 participants.
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.), which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the scanner, the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. Measurements will be evaluated using digital imaging analysis software (Standard Cyborg, Inc.). The different conditions being tested are full weight bearing, partial weight bearing, and non-weight bearing. The effect of limb loading on multiple measures of limb geometry will be evaluated. Limb measurements will include 1) width of the metatarsal heads, 2) width of the calcaneus, 3) foot length, 4) foot height, 5) arch height, 6) medial-lateral width between ankle malleoli, 7) minimum circumference above the ankle malleoli, 8) maximum calf circumference , 9) medial-lateral width of the knee condyles 10) anterior-posterior width at mid patellar tendon, 11) distance from bottom of foot to tibial tubercle.
- Conditions
- Foot Injuries and Disorders
- Being tested
- Structure Sensor
- Keywords
- Ankle Foot Orthosis, Adult, 3D Limb Scanning, Limb Geometry, Limb Loading
- Medical subject headings
- Foot Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structure SensorDevice
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Sensor scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Healthy able-bodied individuals with no history of lower extremity trauma. Receives: Device: Structure Sensor | |
| GROUP 2 | Individuals with unilateral, below knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease). Receives: Device: Structure Sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of the metatarsal heads
Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
Measured: Less than 2 days
Width of the calcaneus
Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
Measured: Less than 2 days
Foot length
Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
Measured: Less than 2 days
Foot height
Distance from the most superior point on the foot distal to the tibialis anterior insertion.
Measured: Less than 2 days
Arch height
Dorsum height at 50% foot length.
Measured: Less than 2 days
Medial-lateral ankle malleoli width
Distance from the lateral malleolus to the medial malleolus.
Measured: Less than 2 days
Minimum ankle circumference
Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
Measured: Less than 2 days
Maximum calf circumference
Maximum calf circumference greater that 5 cm distal to the knee condyles.
Measured: Less than 2 days
Width of the knee condyles
Distance from the medial condyle to the lateral condyle.
Measured: Less than 2 days
Anterior-posterior width at patella
Distance from mid patellar tendon to a parallel point most posterior on the back of the knee.
Measured: Less than 2 days
Tibial tubercle height
Distance from the floor to tibial tubercle.
Measured: Less than 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start27 Oct 2020
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Injuries and DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
- Investigators
- Jason M Wilken, PT, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600102
- Sponsor's protocol ID
- 201907735
- Status last verified
- Jul 2022
- First submitted
- 19 Oct 2020
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry
- ClinicalTrials.gov ID
- NCT04600102
- Acronym / sponsor ID
- 201907735
- Conditions
- Foot Injuries and Disorders
- Keywords
- Ankle Foot Orthosis, Adult, 3D Limb Scanning, Limb Geometry, Limb Loading
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study related activities were delayed due to the COVID pandemic and then terminated to focus on higher priority efforts.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 23 Oct 2020 (actual)
- 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.
Orthotists currently use a range of weight bearing conditions when casting or scanning a patient's limb during the Ankle foot orthosis (AFO) fitting process. This variability in clinical practice is the result of differing opinions regarding the best method for fitting, and a limited understanding of how weight bearing affects the resulting geometry. Few studies have been performed to determine the effect of weight bearing on resulting geometry, or the consistency of the geometry obtained. In this study we seek to evaluate the effect of foot loading on lower limb geometry and the consistency of measurements using low-cost 3D scanning technology, with implications for fitting AFOs.
Detailed description
Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
We will obtain a brief medical history to identify major medical conditions or prior injuries that could influence limb geometry and lead to reliance on an AFO for Group 2 participants.
A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.), which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the scanner, the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. Measurements will be evaluated using digital imaging analysis software (Standard Cyborg, Inc.). The different conditions being tested are full weight bearing, partial weight bearing, and non-weight bearing. The effect of limb loading on multiple measures of limb geometry will be evaluated. Limb measurements will include 1) width of the metatarsal heads, 2) width of the calcaneus, 3) foot length, 4) foot height, 5) arch height, 6) medial-lateral width between ankle malleoli, 7) minimum circumference above the ankle malleoli, 8) maximum calf circumference , 9) medial-lateral width of the knee condyles 10) anterior-posterior width at mid patellar tendon, 11) distance from bottom of foot to tibial tubercle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | – | Device: Structure SensorHealthy able-bodied individuals with no history of lower extremity trauma. |
| GROUP 2 | – | Device: Structure SensorIndividuals with unilateral, below knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).
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 |
|---|---|---|
| Structure SensorA 3D representation of each participant's lower limb geometry will be obtained using a Structure Sensor scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. | Device | GROUP 1, GROUP 2 |
Primary outcome
Width of the metatarsal heads
Time frame: Less than 2 days
Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.
Width of the calcaneus
Time frame: Less than 2 days
Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.
Foot length
Time frame: Less than 2 days
Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).
Foot height
Time frame: Less than 2 days
Distance from the most superior point on the foot distal to the tibialis anterior insertion.
Arch height
Time frame: Less than 2 days
Dorsum height at 50% foot length.
Medial-lateral ankle malleoli width
Time frame: Less than 2 days
Distance from the lateral malleolus to the medial malleolus.
Minimum ankle circumference
Time frame: Less than 2 days
Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.
Maximum calf circumference
Time frame: Less than 2 days
Maximum calf circumference greater that 5 cm distal to the knee condyles.
Width of the knee condyles
Time frame: Less than 2 days
Distance from the medial condyle to the lateral condyle.
Anterior-posterior width at patella
Time frame: Less than 2 days
Distance from mid patellar tendon to a parallel point most posterior on the back of the knee.
Tibial tubercle height
Time frame: Less than 2 days
Distance from the floor to tibial tubercle.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Jason M Wilken, PT, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Foot Injuries and Disorders, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 11 Jul 2022. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Width of the metatarsal heads (time frame: Less than 2 days). The study lists 11 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 11 Jul 2022.