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

Recruiting now

Conditions studied: Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy

In brief

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.

Key facts

Study ID

NCT07009717

Run by

University of Florida

People needed

30

Starts

2025-08-05

Expected to finish

2026-12-31

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• University of Florida — Gainesville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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