The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Great Toe Strength
研究概览
简要总结
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.
详细描述
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:
- 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.
- Explore the relationship between great toe strength and the severity of CIPN symptoms.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (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)
- •Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN using the current clinical reference standard of Nerve conduction study.
排除标准
- •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)
研究组 & 干预措施
CIPN
Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study
干预措施: No intervention (observational study) (Other)
Healthy
Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength
干预措施: No intervention (observational study) (Other)
结局指标
主要结局
Great Toe Strength
时间窗: Baseline
Measured using the ToeScale, the novel device used in this study to evaluate both flexion and extension strength of the great toe
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)
时间窗: Baseline
This is a questionnaire that will be used to evaluate the severity of symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The scores from this questionnaire will be used to conduct a deeper analysis of the differences in great toe strength within the CIPN group.
System Usability Scale (SUS) Questionnaire
时间窗: Baseline
This questionnaire will be administered at the end of the study visit, once the participants have a chance to use the device independently to evaluate their perspective on the satisfaction, ease of use, and comfort of the device.
次要结局
- Gait analysis(Baseline)
- Balance Assessment(Baseline)
- Timed Up and Go (TUG)(Baseline)
- Feedback ineterview(Baseline)