Neuropathy Walks (Cross-sectional)

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

Detailed Description
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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.

Official Title
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Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV

Conditions
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HIV Infections

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV and painful neuropathy<br>Persons living with HIV who also have painful distal sensory polyneuropathy in the feet. | Other: No intervention<br>* No intervention. Study is cross-sectional observational.<br>|
| HIV without painful neuropathy<br>Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet. | Other: No intervention<br>* No intervention. Study is cross-sectional observational.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait - Walking velocity | Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway | Week 0 (one-time) | 
| Gait - Step Length | Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway | Week 0 (one-time) | 
| Gait - Step Time | Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway | Week 0 (one-time) | 
| Gait - Stride Width | Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway | Week 0 (one-time) | 
| Gait - Cadence | Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway | Week 0 (one-time) | 
| Gait - Foot Fall Area | Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway | 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 | Week 0 (one-time) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Endurance | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). | Week 0 (one-time) | 
| Whole Body Strength | Mid-thigh pull test will be used to generate a score expressed as force in pounds or kilograms that is reflective of whole body strength. | Week 0 (one-time) | 
| Pain pressure threshold | Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer | Week 0 (one-time) | 
| Physical Activity | Physical activity characteristics: (1) over a span of 5 days captured via a wrist-band style Actigraph activity monitor; (2) self-reported physical activity over past 7 days using International Physical Activity Questionnaire - Short Form | 5 days from date of all other outcomes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral neuropathy, pain, function