RecruitingNCT07009717

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

The Role Of Great Toe Strength And Its Association With The Severity Of Symptoms Of Chemotherapy-Induced Peripheral Neuropathy (CIPN)


Sponsor

University of Florida

Enrollment

30 participants

Start Date

Aug 5, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

  • Eligibility Criteria for Chemotherapy-Induced Peripheral Neuropathy (CIPN) group:
  • 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.
  • 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)

Exclusion Criteria4

  • 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

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Interventions

OTHERNo intervention (observational study)

No intervention; observational study


Locations(1)

University of Florida

Gainesville, Florida, United States

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NCT07009717


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