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

ConditionsChemotherapy-induced Peripheral Neuropathy (CIPN)Healthy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-90

SponsorUniversity of Florida

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

At least 18 years of old with the ability to independently raise and low (extend or flex) the great toe

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

No intervention (observational study)
Other intervention
No intervention; observational study

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: CIPN1 intervention

Group B: Healthy1 intervention

Trial outcomes

Primary outcomes

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

Time frame

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.

Time frame

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.

Time frame

Baseline

Secondary outcomes

Gait analysis

Five trials of walking at a a self-selected pace will be conducted during which, a markerless motion capture system will be used for video data collection, that will then be used for gait analyses including spatiotemporal and kinematic variables.

Time frame

Baseline

Balance Assessment

The HUR Smart balance platform will be used to evaluate balance using two tests: The romberg test (Stable and unstable conditions) and the limits of stability test.

Time frame

Baseline

Timed Up and Go (TUG)

This is a clinical functional mobility test with a standardized protocol and measured in time (in seconds), which is currently used in clinical practice to assess fall risk. Additionally, the markerless motion capture will be used during this assessment as well to further analyze the biomechanics during different phases of the TUG assessment. We will conduct 3 trials of this assessment.

Time frame

Baseline

Feedback ineterview

This is a semi-structured interview with 7 questions that we developed based on the study protocol and assessments to obtain the participants' overall perspectives on the different aspects of the study, device, and experience. This feedback will be used for secondary thematic analyses, which will inform the development of next generation of the ToeScale as well as to improve the experience of future participants that enroll in our study. This will be the last outcome to be administered to the participants at the end of the study visit.

Time frame

Baseline

Other outcomes

Demographics Questionnaire

Demographic data, including age, gender, history ofathleticism, physical activity, pre-existing conditions, and medical/surgical history, will be collected before the strength and mobility assessments. This data will be used to analyze participant characteristics and potential correlations with outcome measures.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

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