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

NCT07009717 | Recruiting

• 1 other identifier: IRB202401631
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Great Toe Strength

  Measured using the ToeScale, the novel device used in this study to evaluate both flexion and extension strength of the great toe

  Baseline

• Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx)

  This is a questionnaire that will be used to evaluate the severity of symptoms of chemotherapy-induced peripheral neuropathy (CIPN). The scores from this questionnaire will be used to conduct a deeper analysis of the differences in great toe strength within the CIPN group.

  Baseline

• System Usability Scale (SUS) Questionnaire

  This questionnaire will be administered at the end of the study visit, once the participants have a chance to use the device independently to evaluate their perspective on the satisfaction, ease of use, and comfort of the device.

  Baseline

Secondary Outcomes (4)

• Gait analysis

  Baseline

• Balance Assessment

  Baseline

• Timed Up and Go (TUG)

  Baseline

• Feedback ineterview

  Baseline

Other Outcomes (1)

• Demographics Questionnaire

  Baseline

Study Arms (2)

CIPN

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

Other: No intervention (observational study)

Healthy

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

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

No intervention; observational study

CIPN; Healthy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with CIPN and age- and sex- matched healthy controls will be recruited for this study. The recruitment will primarily rely on the resources availale through and rehabilitation specialists working within the University of Florida (UF) Health Cancer Center as well as UF Health Hospitals.

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
• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Interventions

Observation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Hongwu Wang, PhD

CONTACT

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

Raghuveer Chandrashekhar, MS

CONTACT

rchandrashekhar@ufl.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 8, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion of study and publication of the results from the primary outcomes.
• Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request.

Locations

US (1)