An observational study in Chemotherapy-induced Peripheral Neuropathy (CIPN) and Healthy, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by University of Florida · Observational
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.
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.
477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.
This study's planned enrollment of 30 is below the median of 68 across 108 observational studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals with CIPN and age- and sex- matched healthy controls will be recruited for this study. The recruitment will primarily rely on the resources availale through and rehabilitation specialists working within the University of Florida (UF) Health Cancer Center as well as UF Health Hospitals.
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
Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study
Other: No intervention (observational study)
Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength
Other: No intervention (observational study)
No intervention; observational study
Great Toe Strength
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
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)
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
System Usability Scale (SUS) Questionnaire
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
Gait analysis
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
Balance Assessment
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
Timed Up and Go (TUG)
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
Feedback ineterview
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
Demographics Questionnaire
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.
Time frame: Baseline
Plan to share: Yes — The de-identified data might be shared with permission from the funder and PI per request and as appropriate.
Supporting information: Study protocol
Time frame: After completion of study and publication of the results from the primary outcomes.
Access criteria: Only de-identified data will be shared with permission from the funder and PI per request.
Data sharing details ↗ · top.ot.phhp.ufl.edu
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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