SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-27

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SCANREP: Reliability of 3D Lower Limb Scanning

NCT04032041

Foot Injuries and Disorders

TERMINATED

3D Multisegment Foot Model Used for the Clinical Outcome After Ankle and Hindfoot Reconstruction

NCT04822558

Ankle and Hindfoot Alterations

RECRUITING NA

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

NCT06127264

Healthy Ankle Foot Orthosis (AFO) Peripheral Neuropathy

RECRUITING NA

Lower Extremity Fixation In Neuropathic Patients Study

NCT04607044

Neuropathy Charcot; Disease (Etiology)

TERMINATED

The Effect of Strain-counterstrain on Ankle Instability

NCT02025569

Other Instability, Ankle and Foot

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Foot Injuries and Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GROUP 1

Healthy able-bodied individuals with no history of lower extremity trauma.

Structure Sensor

Intervention Type DEVICE

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.

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).

Structure Sensor

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Structure Sensor

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes