Lower Extremity InjuriesLoadsolCPNCT06710119
Effect of Custom Dynamic Orthoses on Forefoot Loading
A study testing Visual Feedback in people with Lower Extremity Injuries, run by University of Iowa at 2 sites in United States.
Trial summary
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Extremity Injuries
- What is being tested?
- Visual Feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion criteria
- Ages: 18-65
- Sustained a function limiting injury below the knee, requiring a carbon fiber custom dynamic orthosis
- Shoe size between women's 8 and 13.5 or men's 6.5 and 13
- Any of the following: weakness of ankle plantarflexors (<4/5 on MMT), limited pain free ankle motion (DF<10deg or PF<20deg), mechanical pain with loading onto hindfoot/midfoot/forefoot (>4/10 on verbal numeric pain rating scale), ankle or hindfoot fusion, candidate for ankle or hindfoot fusion, candidate for amputation secondary to ankle/foot impairment
- Ability to walk 25 feet without using a cane or crutch
- Ability to walk at a slow to moderate pace
- Able to read and write in English and provide written informed consent
Patient Exclusion criteria
- Pain > 9/10 while walking
- Ankle weakness as a result of spinal cord injury or central nervous system pathology
- AFO or CDO prescription that includes a knee brace or goes up to thigh
- Medical or psychological conditions that would preclude functional testing (ex. severe traumatic brain injury, heart condition, clotting disorder, lung condition, stroke, vestibular disorder)
- Nerve, muscle, bone, or other condition limiting function of the contralateral extremity
- BMI greater than 40
- Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing
- Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Cornerstone Prosthetics and Orthotics
Everett, Washington, 98225
Shawna Ziemer, CPO, LPO, 319-353-0431, wilkenlab@healthcare.uiowa.edu
- Active, not recruiting
University of Iowa
Iowa City, Iowa, 52241
About this study
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
Read the detailed description
This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.
Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).
- Conditions
- Lower Extremity Injuries
- Being tested
- Visual Feedback
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Visual Feedback, Foot Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual FeedbackOther
Visual feedback of foot loading during gait.
| Study group | Role | What they receive |
|---|---|---|
| No Visual Feedback | No intervention | Participants will receive typical accommodation training after being prescribed the CDO. |
| Provided Visual Feedback | Active comparator | Participants will receive typical accommodation training with additional visual feedback after being prescribed the CDO. Receives: Other: Visual Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plantar Force (Forefoot)
Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.
Measured: Baseline
Plantar Force Impulse (Forefoot)
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Measured: Baseline
Secondary outcomes (6)
Peak Plantar Force (Midfoot)
Maximum force (N) collected from the midfoot (middle 30% of sensor) during gait.
Measured: Baseline
Plantar Force Impulse (Midfoot)
Plantar force impulse (Ns) across the midfoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Measured: Baseline
Peak Plantar Force (Hindfoot)
Maximum force (N) collected from the hindfoot (proximal 30% of sensor) during gait.
Measured: Baseline
Plantar Force Impulse (Hindfoot)
Plantar force impulse (Ns) across the hindfoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Measured: Baseline
Peak Plantar Force (Total Foot)
Maximum force (N) collected from the total foot (100% of sensor) during gait.
Measured: Baseline
Plantar Force Impulse (Total Foot)
Plantar force impulse (Ns) across the total foot (100% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start18 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity InjuriesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will either receive training with or without visual feedback of foot loading during gait.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Cornerstone Clinics, Everett, WA
- Responsible party
- Principal investigator, Jason Wilken, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710119
- Sponsor's protocol ID
- 202207100
- Acronym
- LoadsolCP
- Status last verified
- Oct 2026
- First submitted
- 25 Nov 2024
- Last updated
- 19 Oct 2026
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Custom Dynamic Orthoses on Forefoot Loading
- ClinicalTrials.gov ID
- NCT06710119
- Acronym / sponsor ID
- LoadsolCP / 202207100
- Conditions
- Lower Extremity Injuries
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics, Visual Feedback, Foot Loading
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Cornerstone Clinics, Everett, WA
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Nov 2024 (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.
The proposed study is designed to evaluate how foot loading changes during initial accommodation to a carbon fiber custom dynamic orthosis (CDO), after targeted training with or without visual feedback of foot loading, and after take-home use of the CDO. This study will quantify initial offloading associated with CDO use and determine if visual feedback of foot loading and additional take-home use of the CDO can further reduce forces, as orthotists work to provide CDOs to patients.
Detailed description
This study is designed to evaluate the effects of initial accommodation, CDO related training, and take-home use on foot loading during gait. In this study, adult participants who experienced an injury below the knee and require a CDO will walk without the CDO, then with the CDO following initial prescription, after training with or without visual force feedback, and after additional take-home use of the CDO. Participants will be randomized to to training with or without visual feedback of foot loading forces.
Wireless force measuring sensors will be used to measure forces under the foot with and without the CDO at each time point. Participants will complete questionnaires to assess and compare various patient outcomes (e.g. pain, quality of life, comfort, satisfaction, and preference).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will either receive training with or without visual feedback of foot loading during gait.
| Arm | Type | Receives |
|---|---|---|
| No Visual Feedback | No intervention | –Participants will receive typical accommodation training after being prescribed the CDO. |
| Provided Visual Feedback | Active comparator | Other: Visual FeedbackParticipants will receive typical accommodation training with additional visual feedback after being prescribed the CDO. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Visual FeedbackVisual feedback of foot loading during gait. | Other | Provided Visual Feedback |
Primary outcome
Peak Plantar Force (Forefoot)
Time frame: Baseline
Maximum force (N) collected from the forefoot (distal 40% of sensor) during gait.
Plantar Force Impulse (Forefoot)
Time frame: Baseline
Plantar force impulse (Ns) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk.
6 secondary outcomes
Peak Plantar Force (Midfoot)
Time frame: Baseline
Plantar Force Impulse (Midfoot)
Time frame: Baseline
Peak Plantar Force (Hindfoot)
Time frame: Baseline
Plantar Force Impulse (Hindfoot)
Time frame: Baseline
Peak Plantar Force (Total Foot)
Time frame: Baseline
Plantar Force Impulse (Total Foot)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Feedback in people with Lower Extremity Injuries, run by University of Iowa at 2 sites 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: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason M Wilken, PT, PhD (319-335-6857, jason-wilken@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plantar Force (Forefoot) (time frame: Baseline). The study lists 2 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 19 Oct 2026.