University of Florida
Gainesville, Florida, 32611, United States
Location status: Recruiting
NCT Number: NCT07009717
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.
Interested in participating?
Request Info18 year–90 year
All sexes
Observational
Gainesville, Florida, 32611, United States
Location status: Recruiting
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:
Inclusion criteria
Exclusion criteria
Eligibility Criteria for Healthy Control group: The participants recruited for this group will be age- and sex- matched to the CIPN group
No intervention; observational study
Time frame: Baseline
Measured using the ToeScale, the novel device used in this study to evaluate both flexion and extension strength of the great toe
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Five trials of walking at a a self-selected pace will be conducted during which, a markerless motion capture system will be used for video data collection, that will then be used for gait analyses including spatiotemporal and kinematic variables.
Time frame: Baseline
The HUR Smart balance platform will be used to evaluate balance using two tests: The romberg test (Stable and unstable conditions) and the limits of stability test.
Time frame: Baseline
This is a clinical functional mobility test with a standardized protocol and measured in time (in seconds), which is currently used in clinical practice to assess fall risk. Additionally, the markerless motion capture will be used during this assessment as well to further analyze the biomechanics during different phases of the TUG assessment. We will conduct 3 trials of this assessment.
Time frame: Baseline
This is a semi-structured interview with 7 questions that we developed based on the study protocol and assessments to obtain the participants' overall perspectives on the different aspects of the study, device, and experience. This feedback will be used for secondary thematic analyses, which will inform the development of next generation of the ToeScale as well as to improve the experience of future participants that enroll in our study. This will be the last outcome to be administered to the participants at the end of the study visit.
Time frame: Baseline
Demographic data, including age, gender, history ofathleticism, physical activity, pre-existing conditions, and medical/surgical history, will be collected before the strength and mobility assessments. This data will be used to analyze participant characteristics and potential correlations with outcome measures.
Contact information is provided by the study sponsor or research team.
Hongwu Wang, PhD
CONTACT
Raghuveer Chandrashekhar, MS
CONTACT
University of Florida
Other
The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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