Great toe strength in people with chemotherapy-induced peripheral neuropathy
Official title: The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Run by University of Florida · NCT07009717 · Data updated 2026-11-12
This research tests whether a small device called ToeScale can measure great toe strength in adults with CIPN and in matched healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | August 5, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07009717 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (≥18) within 3–6 months of starting chemotherapy with nerve-conduction-confirmed CIPN who can voluntarily lift or lower the great toe, can complete questionnaires in English, and do not have comorbidities or toe deformities that affect foot strength.
✕Probably not a fit
Patients with diabetes, significant cardiovascular or thyroid disease, preexisting foot/toe deformities, or other conditions that affect peripheral nerves or foot strength are unlikely to benefit from the results of this device validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will measure great toe strength using the portable ToeScale device in adults with chemotherapy-induced peripheral neuropathy and in age- and sex-matched healthy controls. Participants will complete questionnaires and then perform ToeScale measurements along with balance and gait assessments during an in-person visit. CIPN must be confirmed by nerve conduction study and participants are enrolled 3–6 months after starting chemotherapy, with exclusions for comorbidities or toe deformities that could affect strength. The study also records device usability to determine whether ToeScale is practical for clinical use and sensitive to CIPN-related weakness.
Why it matters
Potential benefit: If successful, ToeScale could provide clinicians a simple, portable way to detect early toe weakness from CIPN and monitor changes in strength to guide balance and mobility support.
How similar studies have gone: Prior work has shown great toe weakness is an early sign of CIPN and relates to mobility, but the ToeScale device itself is novel and its use as a clinical biomarker has not yet been established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. Exclusion Criteria: * 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)
Where it's running
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University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Study coordinator: Hongwu Wang, PhD
- Email: hongwu.wang@phhp.ufl.edu
- Phone: +1 (352) 273-9934
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cryotherapy during weekly paclitaxel to reduce chemotherapy-induced numbness and tingling
This study tests whether applying cryotherapy to hands and feet during weekly paclitaxel helps prevent CIPN in women with breast cancer.
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Electroacupuncture and Exercise for Chemotherapy-Induced Peripheral Neuropathy
This study tests whether adding a structured exercise program to electroacupuncture helps cancer survivors with CIPN more than electroacupuncture alone.
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Virtual exercise program to help with chemotherapy-induced nerve symptoms
This trial tests whether a remote, personalized exercise program (EX-CIPN) can reduce CIPN symptoms and related disability in cancer survivors who have persistent neuropathy after chemotherapy, compared with usual care.
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Acupuncture and compression to prevent chemotherapy-induced nerve damage in breast cancer
This trial will test whether wearing compression garments and/or receiving acupuncture during taxane chemotherapy can prevent chemotherapy-induced peripheral neuropathy in adults with early-stage breast cancer.
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PEA and Scutellaria combined with exercise for chemotherapy-related nerve pain
This trial will see if taking PEA and Scutellaria together with therapeutic exercise helps adults who have nerve pain after chemotherapy.
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Assessing Functional Impairments in CIPN Patients
This study tests how CIPN affects daily function by using functional tests alongside patient self-reports to see how well the tests reflect everyday difficulties.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.