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Completed

NCT Number: NCT04889521

Neuropathy Walks (Cross-sectional)

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

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Virus Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rutgers Physical Therapy Program, Blackwood, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention. Study is cross-sectional observational.

Primary outcomes

  1. Gait - Walking velocity

    Time frame: Week 0 (one-time)

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

  2. Gait - Step Length

    Time frame: Week 0 (one-time)

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

  3. Gait - Step Time

    Time frame: Week 0 (one-time)

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

  4. Gait - Stride Width

    Time frame: Week 0 (one-time)

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

  5. Gait - Cadence

    Time frame: Week 0 (one-time)

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

  6. Gait - Foot Fall Area

    Time frame: Week 0 (one-time)

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

  7. Physical Performance

    Time frame: Week 0 (one-time)

    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

Secondary outcomes

  1. Walking Endurance

    Time frame: Week 0 (one-time)

    Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).

  2. Whole Body Strength

    Time frame: Week 0 (one-time)

    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.

  3. Pain pressure threshold

    Time frame: Week 0 (one-time)

    Pain pressure threshold (expressed in pounds or kilograms of force) at lower extremity landmarks via use of a digital algometer

  4. Physical Activity

    Time frame: 5 days from date of all other outcomes

    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

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Thomas Jefferson University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 17, 2021
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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