Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)

Last updated: February 9, 2026
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Sarcopenia

Polymyositis (Inflammatory Muscle Disease)

Treatment

No intervention (observational study)

Clinical Study ID

NCT07009717
IRB202401631
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 orflex) the great toe

  • Able to consent and complete questionnaires in English independently and have normalto corrected vision (self-reported)

  • Within 3 - 6 months of starting chemotherapy and a confirmed diagnosis of CIPN usingthe current clinical reference standard of Nerve conduction study.

Exclusion

Exclusion Criteria:

  • Comorbidities including but not limited to diabetes, arthritis, hypertension,thyroid disease, and heart disease, . that have been reported to be associated withthe incidence of peripheral neuropathy and/or progression of CIPN.

  • Toe deformities or impairments not caused by CIPN (including but not limited tohallux 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 greattoe 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 orflex) the great toe

  • Able to consent and complete questionnaires in English independently and have normalto corrected vision (self-reported)

  • No known health conditions that have been reported to be associated with differentimpairements in mobility, balance, and muscle strength (particularly in the lowerextremity)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: No intervention (observational study)
Phase:
Study Start date:
August 05, 2025
Estimated Completion Date:
December 31, 2026

Study Description

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:

  1. Check if the ToeScale device is a valid measure of great toe strength (GTS) in people with CIPN and how different GTS is among age- and sex- matched healthy adults.

  2. Explore the relationship between great toe strength and the severity of CIPN symptoms.

  3. Assess how easy it is for participants to use the ToeScale device.

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.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32611
    United States

    Site Not Available

  • University of Florida

    Gainesville 4156404, Florida 4155751 32611
    United States

    Active - Recruiting

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