CLINICAL TRIAL

Voxx Human Performance Technology Socks for Peripheral Nervous System Diseases

Stage I
Recruiting · 18+ · All Sexes · Los Angeles, CA

Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

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About the trial for Peripheral Nervous System Diseases

Eligible Conditions
Chemotherapy-induced Peripheral Neuropathy · Neuropathy;Peripheral · neuropathies · Peripheral Nervous System Diseases

Treatment Groups

This trial involves 2 different treatments. Voxx Human Performance Technology Socks is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Voxx Human Performance Technology Socks
DEVICE
+
Placebo Socks
DEVICE
Experimental Group 2
Voxx Human Performance Technology Socks
DEVICE
+
Placebo Socks
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The applicant needs to be able to fluently understand and communicate in English. show original
The subject has been given information about the study and has agreed to take part show original
A doctor will diagnose you with chemotherapy-induced peripheral neuropathy if you have symptoms such as paresthesias, dysesthesias, allodynia, loss of deep tendon reflexes, decreased vibratory sensation, or symmetrical stocking-glove numbness or paresthesias show original
They had a self-reported average neuropathic pain score of at least 4 on a 10-point scale over the past 1 month. show original
If you have been diagnosed with cancer, it may be classified as stage 1-4, depending on the severity of the disease. show original
The individual has completed chemotherapy with taxanes or platinum-based drugs, vinca alkaloids, or bortezomib within the last 3 months show original
Age ≥ 18 years
You are allowed to take analgesics if the dose has been stable for at least 2 weeks prior to study enrollment, and no new analgesics have been added, discontinued, or changed in the 2 weeks prior to randomization. show original
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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: 6 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 weeks.
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 Voxx Human Performance Technology Socks will improve 1 primary outcome and 5 secondary outcomes in patients with Peripheral Nervous System Diseases. Measurement will happen over the course of 6 weeks.

Change in cancer-related symptom experience
6 WEEKS
Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome.
6 WEEKS
Change in quality of life measurement
6 WEEKS
Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29. The minimum value is 50 and maximum value is 110, and a lower score means a better outcome.
6 WEEKS
Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale)
6 WEEKS
Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 24, and a lower score means a better outcome.
6 WEEKS
Feasibility of Voxx Socks use
6 WEEKS
Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.
6 WEEKS
Change in subjective measurement of chemotherapy-induced peripheral neuropathy
6 WEEKS
Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome.
6 WEEKS
Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test)
6 WEEKS
Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.
6 WEEKS

Patient Q & A Section

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

Can peripheral nervous system diseases be cured?

The treatment that a patient is given can impact on the course of their pain and disability. It can be difficult to determine what treatment method will be most effective for a particular case and these need to be assessed both from a medical and a psychological perspective. Although some rare conditions may respond to specific treatments there is no single way of managing the range of causes of pain.

Anonymous Patient Answer

How many people get peripheral nervous system diseases a year in the United States?

About 14 million US adults a year are diagnosed with peripheral nervous system (PNS) disorders. This accounts for 22% of American adults with a diagnosis.

Anonymous Patient Answer

What causes peripheral nervous system diseases?

While some evidence of a strong genetic component exists for some peripheral nerve diseases, the mechanisms by which genes modify the risk of these disorders are not clear. Some environmental toxins, such as asbestos and cigarette smoke, may cause some peripheral nervous system diseases. The effect of environmental factors on peripheral nervous system diseases may differ across the types of disease, and may in part explain why individuals with certain diseases may be predisposed to developing another disease in the future. The risk of developing peripheral nervous system diseases seems to be positively associated with age, which may be a result of environmental changes that accumulate with age.

Anonymous Patient Answer

What are common treatments for peripheral nervous system diseases?

Current therapies for peripheral neuropathies are limited. The best options are often based on the type of lesion, as well as patient preferences and available expertise. This article presents a summary of the treatment approaches for peripheral neuropathies.

Anonymous Patient Answer

What is peripheral nervous system diseases?

PNS disorders are common and constitute a major cause of disability. They are potentially disabling and can sometimes interfere with the patient's daily activity or even lead to death. Moreover, they are treated mainly by physical therapy, with or without medications, which are usually expensive and less effective or well tolerated, although in recent years medications are sometimes prescribed to provide rapid symptom control. This issue is not being emphasized by health professionals during patient follow-up. Finally, current neurologic practices have no standardized documentation or management. A proper assessment of peripheral nervous system disorders based on a careful medical history and physical examination by a competent professional is the cornerstone of a successful clinical management.

Anonymous Patient Answer

What are the signs of peripheral nervous system diseases?

Nerves of the PNS are involved in the disease and they can be affected on different levels, from the skin manifestations (which give information about the localisation) to the peripheral and central nervous involvement and in most cases there is no pain, therefore no symptom. PN may also affect other PN or SNS.

Anonymous Patient Answer

Have there been other clinical trials involving voxx human performance technology socks?

Findings from a recent study of this study should assist users and caregivers who are not only interested but also concerned about choosing a proper athletic sock for athletes. The design of the voxx sock should aim at the control of the heat and moisture loss, the prevention of the skin from drying out and the overall comfort of the foot.

Anonymous Patient Answer

How does voxx human performance technology socks work?

Sock devices do not improve exercise performance and are associated with a higher incidence of adverse health effects. There are no indications to suggest that Voxx garments influence recovery from exercise or the incidence of adverse health effects.

Anonymous Patient Answer

Who should consider clinical trials for peripheral nervous system diseases?

The study showed that only a small minority of patients with PNSDs consider participating in clinical trials, and there would be no benefit for all. Patients and families with PNSDs should be aware that they are likely to feel more uncomfortable and more pressure in clinical trials, but there will be no benefit for most patients on clinical trials.

Anonymous Patient Answer

Does peripheral nervous system diseases run in families?

While familial SPG, SPS, and neuropathy are all autosomal dominant conditions, SPG, SPS, and CMT type 1A are all multifactorial conditions due to the different genes and environmental factors responsible for each condition. SSP and CMT type 2a are both multifactorial as well, but more so than other spastic paraplegia types. There are no families with a combination of SSP, SPS, and CMT type 2a. Spastic paraplegia family history has been reported in the medical literature for at least two decades, but it is still not recognized as a clinical concept.

Anonymous Patient Answer

Is voxx human performance technology socks safe for people?

Results of this study show that use of the Vita VF-VX3 Vx-M socks is safe for people. The study also shows that some people are not satisfied in using the socks. Implication for practice Recent findings shows that use of the Vita VF-VX3® socks by people is safe. However, it is recommended that further studies are needed in order to improve user satisfaction about sock use.

Anonymous Patient Answer

What is the average age someone gets peripheral nervous system diseases?

PNS diseases (peripheral neuropathies) are more common among individuals older than 60 years of age. This is an observation which should make clinicians more cautious when treating these patients because of the likelihood of more complicated or delayed diagnoses with increasing age and may ultimately lead patients to more urgent interventions such as surgery or biopsy when the disease is already in a life threatening state.

Anonymous Patient Answer
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