Neuropathy Walks (Cross-sectional)

Rutgers, The State University of New Jersey75 enrolled

Overview

Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).

The overall goal of this study is to explore the impact of HIV-associated distal sensory polyneuropathy on physical performance, physical activity, and pain pressure threshold. The aim is to determine if the presence of painful distal sensory polyneuropathy in the feet adversely affects physical performance, physical activity, and pain pressure threshold in PLHIV.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infections

Interventions

No interventionOTHER

No intervention. Study is cross-sectional observational.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of HIV infection currently treated with antiretroviral therapy (ART) * cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3 * 18-64 years of age * able to read and write in English * means to travel to a study site * Additional inclusion for cohort with painful neuropathy in the feet: * presence of peripheral neuropathy symptoms in feet * average daily self-reported pain in the feet of at least 3/10 on a 0-10 numerical pain scale * pain in the feet present for at least the past 3 months * no changes in medications used to manage pain in the past 4 weeks Exclusion Criteria: * current opportunistic infection(s) * cluster of differentiation 4 cell (CD4 cell) count \<200 cells/mm3 * dementia * uncontrolled psychiatric disorder * wounds or sores on the feet * musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait * pregnancy

Locations (2)

Rutgers Physical Therapy Program

Blackwood, New Jersey, United States

Rutgers Physical Therapy Program

Newark, New Jersey, United States

Outcomes

Primary Outcomes

Gait - Walking velocity

Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Gait - Step Length

Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Gait - Step Time

Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Gait - Stride Width

Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Gait - Cadence

Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Gait - Foot Fall Area

Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway

Time frame: Week 0 (one-time)

Physical Performance

Physical performance score generated via the Short Physical Performance Battery. (SPPB). SPPB procedures generate a total score reflective of physical performance. Minimum score=0; maximum score=12; lower score=worse outcome

Time frame: Week 0 (one-time)

Secondary Outcomes

Walking Endurance

Data from ClinicalTrials.gov

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