Neuropathy Walks (Cross-sectional)

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04889521
• Other study ID #: Pro2020003234(cross-sec)
• Status: Recruiting
• Start date: April 22, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: August 2023
• Source: Rutgers, The State University of New Jersey
• Contact: David Kietrys, PhD
• Phone: 856-566-7186
• Email: kietrydm[@]shp.rutgers.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• No intervention
No intervention. Study is cross-sectional observational.

Locations

Country	Name	City	State
United States	Rutgers Physical Therapy Program	Blackwood	New Jersey
United States	Rutgers Physical Therapy Program	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait - Walking velocity	Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	Gait - Step Length	Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	Gait - Step Time	Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	Gait - Stride Width	Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	Gait - Cadence	Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	Gait - Foot Fall Area	Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway	Week 0 (one-time)
Primary	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	Walking Endurance	Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).	Week 0 (one-time)
Secondary	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)
Secondary	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)
Secondary	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