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Observational Study on Great Toe Strength and Chemotherapy-Induced Peripheral Neuropathy (CIPN)

This study is looking at the relationship between the strength of your big toe and symptoms of chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of cancer treatment that can cause nerve damage. Researchers want to see if a new portable device called ToeScale can accurately measure big toe strength in people with CIPN and healthy adults. They also want to understand how big toe strength relates to the severity of CIPN symptoms and how easy the ToeScale device is to use. You might be able to join if you are 18 to 90 years old, can move your big toe independently, and are 3-6 months into chemotherapy treatment. The study aims to see if ToeScale is a reliable tool for measuring big toe strength and how it connects to nerve issues from chemotherapy.

Study design
This is an observational study with a planned enrollment of 30 participants. It is not testing a new intervention or drug.
What's involved
As a participant, you will complete questionnaires, and have your great toe strength, balance, and gait assessed during a single study visit.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07009717

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

Recruiting
Not specifiedAges 18–90Observational
University of Florida
~30 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:No intervention (observational study)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Great Toe Strength
Measured over Baseline
+2 more outcomes measured

Conditions

Chemotherapy-induced Peripheral Neuropathy (CIPN)
Healthy

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Chemotherapy-Induced Peripheral NeuropathyHealthy

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Hongwu Wang, PhD
[email protected]
+1 (352) 273-9934
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Great Toe StrengthBaseline

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

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

    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.

  • System Usability Scale (SUS) QuestionnaireBaseline

    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.