Neuropathy Walks (Cross-sectional)

March 4, 2025 updated by: David Kietrys, Rutgers, The State University of New Jersey

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • Rutgers Physical Therapy Program
      • Newark, New Jersey, United States, 07101
        • Rutgers Physical Therapy Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Persons living with HIV. Half of sample will include concurrent painful distal sensory neuropathy in the feet.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 0 (one-time)
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.
Week 0 (one-time)
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
Week 0 (one-time)
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
5 days from date of all other outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

Thomas Jefferson University

Investigators

  • Principal Investigator: David Kietrys, PhD, Rutgers School of Health Professions

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2022

Primary Completion (Actual)

September 13, 2024

Study Completion (Actual)

September 13, 2024

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

May 14, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2020003234(cross-sec)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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