Recruiting

Great Toe Strength

Sponsor:

University of Florida

Code:

NCT07009717

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

No intervention (observational study)

Study Details

Brief 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.

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)

Healthy

Study ID

NCT07009717

Start date

Aug 5, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

CIPN

Individuals with chemotherapy-induced peripheral neuropathy with a confirmed diagnosis using the nerve conduction study

Healthy

Healthy adults with no known health conditions affecting their mobility, balance, or lower extremity muscle strength

Interventions

No intervention (observational study)

No intervention; observational study

Primary outcome measure

  • Great Toe Strength [ Time Frame: Baseline ]
  • Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) [ Time Frame: Baseline ]
  • System Usability Scale (SUS) Questionnaire [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Hongwu Wang, PhD

+1 (352) 273-9934hongwu.wang@phhp.ufl.edu

Raghuveer Chandrashekhar, MS

rchandrashekhar@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32611

Contacts

Hongwu Wang, PhD

352-273-9934hongwu.wang@phhp.ufl.edu

Principal Investigator:

Hongwu Wang, PhD

More Information

Sponsor

University of Florida

Last update posted

Feb 10, 2026

Last verified

Aug, 2025

Keywords

  • Great Toe strength
  • chemotherapy-induced peripheral neuropathy
  • muscle weakness
  • clinical biomarker
  • force development curve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-10.