Clinical trial NCT04889521: Neuropathy Walks (Cross-sectional)
Official title: Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: peripheral neuropathy
pain
function
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2021-05-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons living with HIV. Half of sample will include concurrent painful distal sensory neuropathy in the feet.

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait - Walking velocity
timeFrame: Week 0 (one-time)
measure: Gait - Step Length
timeFrame: Week 0 (one-time)
measure: Gait - Step Time
timeFrame: Week 0 (one-time)
measure: Gait - Stride Width
timeFrame: Week 0 (one-time)
measure: Gait - Cadence
timeFrame: Week 0 (one-time)
measure: Gait - Foot Fall Area
timeFrame: Week 0 (one-time)
measure: Physical Performance
timeFrame: Week 0 (one-time)
Secondary outcomes:
measure: Walking Endurance
timeFrame: Week 0 (one-time)
measure: Whole Body Strength
timeFrame: Week 0 (one-time)
measure: Pain pressure threshold
timeFrame: Week 0 (one-time)
measure: Physical Activity
timeFrame: 5 days from date of all other outcomes
Other outcomes:
Locations:
city: Blackwood
country: United States
facility: Rutgers Physical Therapy Program
state: New Jersey
city: Newark
country: United States
facility: Rutgers Physical Therapy Program
state: New Jersey
Study officials:
affiliation: Rutgers School of Health Professions
name: David Kietrys, PhD
role: PRINCIPAL_INVESTIGATOR
References: