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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIPN | Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study |
| |
| Healthy | Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (observational study) | Other | No intervention; observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Balance Assessment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongwu Wang, PhD | Contact | +1 (352) 273-9934 | hongwu.wang@phhp.ufl.edu | |
| Raghuveer Chandrashekhar, MS | Contact | rchandrashekhar@ufl.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32611 | United States |
The de-identified data might be shared with permission from the funder and PI per request and as appropriate.
After completion of study and publication of the results from the primary outcomes.
Only de-identified data will be shared with permission from the funder and PI per request.
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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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. |
| 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. | 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. | Baseline |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |