Adult ALLPRMRP-NormsNCT04800510
Iterative Design of Custom Dynamic Orthoses
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Adult ALL and Healthy, run by University of Iowa at 1 site in United States.
Trial summary
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- What is being tested?
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between the ages of 18 and 50
- Shoe size between women's 8 and 13.5 or men's 6.5 and 12
- Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- Full active range of motion of the bilateral lower extremities and spine
- Ability to hop without pain
- Ability to perform a full squat without pain
- Ability to read and write in English and provide written informed consent
Who cannot join
- Diagnosed moderate or severe brain injury
- Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairment that would interfere with instructions given during testing
- Require an assistive device
- Wounds to the foot or calf that would prevent CDO use
- BMI greater than 35
- Pregnancy - Per participant self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, participants will be withdrawn from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
The proposed study evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Read the detailed description
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
- Being tested
- Carbon Fiber Custom Dynamic Orthosis (CDO)
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Fiber Custom Dynamic Orthosis (CDO)Device
Also called Ankle Foot Orthosis
The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
| Study group | Role | What they receive |
|---|---|---|
| NoCDO, CDOA, CDOB, CDOC | Experimental | Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, CDOA, CDOC, CDOB | Experimental | Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, CDOB, CDOA, CDOC | Experimental | Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, CDOB, CDOC, CDOA | Experimental | Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, CDOC, CDOA, CDOB | Experimental | Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
| NoCDO, CDOC, CDOB, CDOA | Experimental | Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Receives: Device: Carbon Fiber Custom Dynamic Orthosis (CDO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint Contact Stress-Time Exposure
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
Measured: Baseline
Secondary outcomes (15)
Ankle Range of Motion
Peak dorsiflexion angle (degrees) during gait.
Measured: Baseline
Peak Ankle Moment
Peak ankle moment (Nm/kg) during gait.
Measured: Baseline
Peak Ankle Power
Peak ankle power (W/kg) during gait.
Measured: Baseline
Plantar Force (Total Foot)
Force data (N) collected across the total foot measured between the foot and orthosis during gait.
Measured: Baseline
Plantar Force (Forefoot)
Force data (N) collected across the forefoot (distal 40% of insole) measured between the foot and orthosis during gait.
Measured: Baseline
Plantar Force (Midfoot)
Force data (N) collected across the midfoot (middle 30% of insole) measured between the foot and orthosis during gait.
Measured: Baseline
Plantar Force (Hindfoot)
Force data (N) collected across the hindfoot (proximal 30% of insole) measured between the foot and orthosis during gait.
Measured: Baseline
Four Square Step Test (4SST)
The 4SST (s) is a standardized timed test of balance and agility.
Measured: Baseline
Sit to Stand 5 Times (STS5)
STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to stand up and sit down 5 times as fast as possible.
Measured: Baseline
Numerical Pain Rating Scale
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Measured: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score. The survey asks users to indicate how much they agree with each statement on a scale from - Strongly Agree (5) to Strongly Disagree (0) with a Don't Know/Not Applicable option. The average score across all questions was calculated and reported, larger scores indicate a better outcome associated with that device. The maximum possible score is a 5 and the minimum possible score is a 0.
Measured: Baseline
Soleus Muscle Force (N)
Peak Soleus muscle forces (N) will be estimated using an Opensim model
Measured: Baseline
Gastrocnemius Muscle Force (N)
Peak Gastrocnemius muscle forces (N) will be estimated using an OpenSim model
Measured: Baseline
Modified Socket Comfort Score (Comfort)
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable.
Measured: Baseline
Modified Socket Comfort Score (Smoothness)
Comfort scores range from 0 = least smooth to 10 = most smooth.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start21 Apr 2021
- Primary completion25 Jun 2022
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult ALLStudies 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
- Crossover
- Model description
- All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
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
- NCT04800510
- Sponsor's protocol ID
- 202002131
- Other IDs
- CDMRP-PR172087
- Acronym
- PRMRP-Norms
- Status last verified
- Dec 2023
- First submitted
- 11 Mar 2021
- Last updated
- 30 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iterative Design of Custom Dynamic Orthoses and Comprehensive Design of Musculoskeletal Model
- ClinicalTrials.gov ID
- NCT04800510
- Acronym / sponsor ID
- PRMRP-Norms / 202002131
- Keywords
- Gait Analysis, Ankle Foot Orthosis, Carbon Fiber, Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Posted 5 Dec 2023
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 evaluates the effect of carbon fiber brace design on forces across the ankle joint. It is expected that carbon fiber braces can be designed to reduce forces in the ankle. In this study, brace geometry will be varied to determine how these changes influence the forces experienced by ankle cartilage. The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Detailed description
The purpose of this study is to refine a pre-existing musculoskeletal model and finalize the procedures for inputting multiple data sources into the model to evaluate ankle articular contact stresses.
Healthy adult participants will complete testing using three generic sized carbon fiber custom dynamic orthoses (CDOs) and with no CDO. Participants will be blinded to the design variation of each device and will only know them as CDO-A, CDO-B, or CDO-C. Testing will be completed under 4 conditions: No-CDO, CDO-A, CDO-B, CDO-C, with each bracing condition (A/B/C) representing a CDO design variant. Physical performance measures will incorporate tests of agility, speed, and lower limb power to ensure that changes to device design do not negatively affect physical function. Questionnaires will be used to evaluate participants' current and desired activity level, pain with and without CDO use, satisfaction with the devices, perception of comfort and smoothness between devices, and preference between CDOs. Semi-structured interviews will be completed to fully capture the participant's perspective. Lower limb forces and motion will be assessed using a computerized motion capture system and force plates in the floor. Forces between the foot and CDO will be measured using force sensing insoles, and muscle activity data will be collected using surface electromyography. Devices will be mechanically tested, and participant demographic and anthropometric data will be recorded.
The information obtained from this study will help refine the musculoskeletal model data input methods to be used in future studies. The knowledge that will be gained from this investigation has the potential to substantially improve the long-term efficacy and efficiency of the musculoskeletal model and help improve ankle foot orthosis
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- All participants will use three generic sized carbon fiber custom dynamic orthoses (CDOs). Each CDO will differ from the others in design and will be labeled as CDO-A, CDO-B and CDO-C. Participants will be randomly assigned to one of six CDO testing sequences (ABC, ACB, BCA, BAC, CAB, CBA) to prevent testing order from influencing study results.
| Arm | Type | Receives |
|---|---|---|
| NoCDO, CDOA, CDOB, CDOC | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. |
| NoCDO, CDOA, CDOC, CDOB | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. |
| NoCDO, CDOB, CDOA, CDOC | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. |
| NoCDO, CDOB, CDOC, CDOA | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. |
| NoCDO, CDOC, CDOA, CDOB | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. |
| NoCDO, CDOC, CDOB, CDOA | Experimental | Device: Carbon Fiber Custom Dynamic Orthosis (CDO)Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and 50
- Shoe size between women's 8 and 13.5 or men's 6.5 and 12
- Healthy individuals without a current complaint of lower extremity pain, spine pain, or medical or neuromusculoskeletal disorders that have limited participation in work or exercise in the last 6 months
- Full active range of motion of the bilateral lower extremities and spine
- Ability to hop without pain
Key exclusion criteria (8 listed)
- Diagnosed moderate or severe brain injury
- Prior lower extremity injury resulting in surgery or limiting function for greater than 6 weeks
- Diagnosis of a physical or psychological condition that would preclude testing (e.g. cardiac condition, clotting disorder, pulmonary condition)
- Visual or hearing impairment that would interfere with instructions given during testing
- Require an assistive device
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 |
|---|---|---|
| Carbon Fiber Custom Dynamic Orthosis (CDO)Also: Ankle Foot OrthosisThe CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee. | Device | NoCDO, CDOA, CDOB, CDOC, NoCDO, CDOA, CDOC, CDOB, NoCDO, CDOB, CDOA, CDOC, NoCDO, CDOB, CDOC, CDOA, NoCDO, CDOC, CDOA, CDOB, NoCDO, CDOC, CDOB, CDOA |
Primary outcome
Joint Contact Stress-Time Exposure
Time frame: Baseline
Joint contact stress-time exposure (MPA-s/gait cycle) will be estimated using a participant specific musculoskeletal model. The model included surface geometry of each participants tibia and talus. Contact stress -time exposure, measured in MPa-s, was calculated at 13 points across the gait cycle. Higher values indicate greater contact stress-time exposure.
15 secondary outcomes
Ankle Range of Motion
Time frame: Baseline
Peak Ankle Moment
Time frame: Baseline
Peak Ankle Power
Time frame: Baseline
Plantar Force (Total Foot)
Time frame: Baseline
Plantar Force (Forefoot)
Time frame: Baseline
Plantar Force (Midfoot)
Time frame: Baseline
Plantar Force (Hindfoot)
Time frame: Baseline
Four Square Step Test (4SST)
Time frame: Baseline
Sit to Stand 5 Times (STS5)
Time frame: Baseline
Numerical Pain Rating Scale
Time frame: Baseline
The Orthotics Prosthetics Users' Survey (OPUS)
Time frame: Baseline
Soleus Muscle Force (N)
Time frame: Baseline
Gastrocnemius Muscle Force (N)
Time frame: Baseline
Modified Socket Comfort Score (Comfort)
Time frame: Baseline
Modified Socket Comfort Score (Smoothness)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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?
A study testing Carbon Fiber Custom Dynamic Orthosis (CDO) in people with Adult ALL and Healthy, 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?
The sponsor lists 7 inclusion and 8 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 30 Jan 2026. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Joint Contact Stress-Time Exposure (time frame: Baseline). 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 30 Jan 2026.