Great toe strength in people with chemotherapy-induced peripheral neuropathy
The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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 |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT07009717 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Gainesville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.