Clinical trial Recruiting at 1 site Observational Ages 18 to 90

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 typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment30 (estimated)
SponsorUniversity of Florida
Academic / other
Drugs / interventionsChemotherapy
Locations1 site (Gainesville, Florida)
StatusRecruiting
StartedAugust 5, 2025
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedNovember 3, 2026
Trial IDNCT07009717 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

  • University of Florida
    Gainesville, Florida, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.