Neuropathy Walks (Cross-sectional)

NCT04889521 | Completed

• 1 other identifier: Pro2020003234(cross-sec)
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

HIV Infections

Keywords

peripheral neuropathy; pain; function

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Walking Endurance

  Week 0 (one-time)

• Whole Body Strength

  Week 0 (one-time)

• Pain pressure threshold

  Week 0 (one-time)

• Physical Activity

  5 days from date of all other outcomes

Study Arms (2)

HIV and painful neuropathy

Persons living with HIV who also have painful distal sensory polyneuropathy in the feet.

Other: No intervention

HIV without painful neuropathy

Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet.

Other: No intervention

Interventions

No intervention OTHER

No intervention. Study is cross-sectional observational.

HIV and painful neuropathy; HIV without painful neuropathy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• diagnosis of HIV infection currently treated with antiretroviral therapy (ART)
• cluster of differentiation 4 cell (CD4 cell) count of at least 200 cells/mm3
• years of age
• able to read and write in English
• means to travel to a study site
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Thomas Jefferson University: collaborator

Study Sites (2)

Rutgers Physical Therapy Program

Blackwood, New Jersey, 08012, United States

Location

Rutgers Physical Therapy Program

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

HIV Infections; Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• David Kietrys, PhD

  Rutgers School of Health Professions

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: April 22, 2022
• Primary Completion: September 13, 2024
• Study Completion: September 13, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)