Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Официальное название

The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Обзор

Great Toe Strength (GTS) is a potential clinical biomarker that has been associated with functional mobility and health; Additionally, GTS has been identified in the literature as one of the early symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The purpose of this research study is to evaluate GTS in individuals with CIPN and healthy adults using ToeScale and see how it relates to nerve issues from chemotherapy. Additionally, we aim to assess the usability of the novel GTS assessment device, ToeScale among the participants. As a part of this study visit, you will complete some questionnaires followed by GTS and balance and gait assessments.

Подробное описание

Chemotherapy-induced peripheral neuropathy, or CIPN, is a common side effect of cancer treatment. It affects about 30-40% of people with cancer and up to 100% of those who receive chemotherapy that can harm nerves. One of the early signs of CIPN is weakness in the muscles of the great toe, which is associated with movement and balance.

Current methods used to measure the strength of the great toe muscles have several drawbacks. They are not very sensitive to changes in strength, require expensive equipment or trained professionals, and can be subjective. To address these limitations, a new portable device called ToeScale was developed. This study aims to:

1. Check if the ToeScale device is a valid measure of great toe strength (GTS) in people with CIPN and how different GTS is among age- and sex- matched healthy adults. 2. Explore the relationship between great toe strength and the severity of CIPN symptoms. 3. Assess how easy it is for participants to use the ToeScale device.

In simpler terms, this study wants to see if the new device is reliable and accurate, how well it measures GTS in people with CIPN, and whether it's easy to use.

Вмешательства

• Другое No intervention (observational study)
  No intervention; observational study

Первичные конечные точки

• Great Toe Strength [Срок оценки: Baseline]
• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) [Срок оценки: Baseline]
• System Usability Scale (SUS) Questionnaire [Срок оценки: Baseline]

Вторичные конечные точки (4)

• Gait analysis [Срок оценки: Baseline]
• Balance Assessment [Срок оценки: Baseline]
• Timed Up and Go (TUG) [Срок оценки: Baseline]
• Feedback ineterview [Срок оценки: Baseline]

Критерии участия

Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:

Критерии включения

• At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
• Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
• Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN using the current clinical reference standard of Nerve conduction study.

Критерии исключения

• Comorbidities including but not limited to diabetes, arthritis, hypertension, thyroid disease, and heart disease, . that have been reported to be associated with the incidence of peripheral neuropathy and/or progression of CIPN.
• Toe deformities or impairments not caused by CIPN (including but not limited to hallux valgus/varus, hallux limitus, hallux rigidus, hammer toe deformity, claw toe, bunions, webbed toes)
• Self-reported impairment or impact on the strength of the foot, ankle, and/or great toe due to past medical or surgical history.

Eligibility Criteria for Healthy Control group: The participants recruited for this group will be age- and sex- matched to the CIPN group

• Inclusion Criteria:
• At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe
• Able to consent and complete questionnaires in English independently and have normal to corrected vision (self-reported)
• No known health conditions that have been reported to be associated with different impairements in mobility, balance, and muscle strength (particularly in the lower extremity)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• University of Florida — Gainesville

Идентификаторы

NCT: NCT07009717 · IRB202401631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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