CLINICAL TRIAL

Carbon Fiber Custom Dynamic Orthosis (CDO) for ALL, Adult

Waitlist Available · 18 - 65 · All Sexes · Iowa City, IA

This study is evaluating whether a carbon fiber brace can help reduce forces across the ankle joint.

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About the trial for ALL, Adult

Eligible Conditions
ALL, Adult · Healthy Subjects (HS)

Treatment Groups

This trial involves 3 different treatments. Carbon Fiber Custom Dynamic Orthosis (CDO) is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Carbon Fiber Custom Dynamic Orthosis (CDO)
DEVICE
Experimental Group 2
Carbon Fiber Custom Dynamic Orthosis (CDO)
DEVICE
Experimental Group 3
Carbon Fiber Custom Dynamic Orthosis (CDO)
DEVICE

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The range for women's shoe sizes is 8 to 13.5, and for men's it is 6.5 to 12. show original
were recruited from the community Healthy individuals without pain in their lower extremities, spine, or medical or neuromusculoskeletal disorders that have limited their participation in work or exercise in the last 6 months were recruited from the community. show original
The text states that the person has the ability to hop without pain show original
Ability to perform a full squat without pain
Between the ages of 18 and 50
Full active range of motion of the bilateral lower extremities and spine
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Carbon Fiber Custom Dynamic Orthosis (CDO) will improve 1 primary outcome, 13 secondary outcomes, and 5 other outcomes in patients with ALL, Adult. Measurement will happen over the course of Baseline.

Numerical Pain Rating Scale
BASELINE
Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable.
Modified Socket Comfort Score (Comfort and Smoothness)
BASELINE
Comfort scores range from 0 = most uncomfortable to 10 = most comfortable, and from 0 = least smooth to 10 = most smooth.
The Orthotics Prosthetics Users' Survey (OPUS)
BASELINE
Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.
Sit to Stand 5 Times (STS5)
BASELINE
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.
Ankle Range of Motion
BASELINE
Ankle range of motion (degrees) during gait.
Peak Ankle Moment
BASELINE
Peak ankle moment (Nm/kg) during gait.
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Who is running the study

Principal Investigator
J. W.
Prof. Jason Wilken, Associate Professor
University of Iowa

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for healthy subjects (hs)?

The current study provided the first detailed, updated listing of common treatments for healthy subjects. It revealed that some commonly used treatments are ineffective, dangerous, and costly, if not outright dangerous and costly. Patients and health care providers should expect to hear most of the therapies tested, and possibly should consider treatment plans with fewer and simpler therapies to minimize risks.

Anonymous Patient Answer

How many people get healthy subjects (hs) a year in the United States?

In the United States a year, about 1.5 million people are being used as controls, whereas an equal number might be tested for a clinical disorder, if case control studies were carried out in a healthy US adult population.

Anonymous Patient Answer

Can healthy subjects (hs) be cured?

Results from a recent paper demonstrate that a significant proportion of HSCs will be cured with a low rate of toxicity (if the treatment is not repeated). There is therefore a chance that HSC treatment could become a possible way to save a significant number of lives of patients in the future and we therefore argue further that in future clinical trials with HSCs there should also be a control group of HSCs for comparison.

Anonymous Patient Answer

What is healthy subjects (hs)?

Healthy subjects (hs) are individuals with no known health problems; therefore, they are a ideal subject group for use in clinical studies. In addition, hs are an equally effective and valid group of subjects for use in drug treatment studies.

Anonymous Patient Answer

What are the signs of healthy subjects (hs)?

Hs often exhibit depressive symptoms or anxiety symptoms or both. Hs have a history of psychiatric disorders and an increase in stress can worsen the symptoms of depression and anxiety. Hs can exhibit a more intense response to stress.

Anonymous Patient Answer

What causes healthy subjects (hs)?

There is considerable variation in the risk factors for hs and there is no reason to suspect that hs will be less vulnerable to the deleterious effects of environmental hazards than healthy people.

Anonymous Patient Answer

Has carbon fiber custom dynamic orthosis (cdo) proven to be more effective than a placebo?

At this time, we recommend that a randomized controlled study with long period or the meta analysis of the effect of a carbon fiber dynamic orthosis should be conducted on healthy subjects. We also emphasize that it is not appropriate to combine the clinical effect of the carbon fiber dynamic orthosis with the efficacy of the carbon fiber dynamic orthosis made from other material such as rubber fiber, steel fiber, etc. because the two types of carbon fiber dynamic orthosis have different properties.

Anonymous Patient Answer

Does healthy subjects (hs) run in families?

Healthy subjects has a strong genetic basis for familial aggregation. This is not solely explained by a general hereditary tendency of those parents, but by a distinct genetic marker that seems to affect not only the general ability of that person, but also the ability to manage chronic illness. However, the results of this study do not support the hypothesis that healthy subjects in a family with chronic liver disease are more resistant to developing chronic liver disease than healthy subjects.

Anonymous Patient Answer

What is the average age someone gets healthy subjects (hs)?

The survey-based study of frequency of hot flashes should be interpreted cautiously in light of limitations such as a reliance on self-report and lack of a criterion for determining when and how to treat health complaints.

Anonymous Patient Answer

How does carbon fiber custom dynamic orthosis (cdo) work?

Cdo improves gait in patients with multiple sclerosis, thus contributing to a functional recovery and a reduction or absence of spasticity control. However, these results do not imply a therapeutic or functional superiority of Cdo on respect to a previous conventional ankle-foot orthosis.

Anonymous Patient Answer

Who should consider clinical trials for healthy subjects (hs)?

Trial administrators and investigators should be aware of potential biases that may prevent a fair view of health disparities. Heterogeneity in a population is a source of bias. In addition to the patient and provider selection processes the study design and power calculations should also be reviewed to minimize the potential for bias.

Anonymous Patient Answer

How serious can healthy subjects (hs) be?

[HS] may represent the vast majority of subjects who are eligible for medical studies such as [FDA] clinical trials of new medicines. [HS] also represent the majority of patients diagnosed with [DS] or [ID] if their symptoms are judged to be of sufficient severity to qualify for treatment in clinical trials. [HS] may be considered a [model group] for any study involving any clinical population(s) of medical interest.

Anonymous Patient Answer
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