Neuropathy Walks (Cross-sectional)

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04889521
• Collaborator: Thomas Jefferson University (Other)
• Enrollment: 72
• Locations: 2
• Anticipated Duration (Months): 13.2
• Patients Per Site: 36
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Other: No intervention

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 Design

• Study Type: Observational
• Anticipated Enrollment: 72 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV
• Actual Study Start Date: Apr 22, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: May 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Gait - Walking velocity [Week 0 (one-time)]

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

2. Gait - Step Length [Week 0 (one-time)]

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

3. Gait - Step Time [Week 0 (one-time)]

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

4. Gait - Stride Width [Week 0 (one-time)]

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

5. Gait - Cadence [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 [Week 0 (one-time)]

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

7. Physical Performance [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 Outcome Measures

1. Walking Endurance [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 [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 [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Physical Therapy Program	Blackwood	New Jersey	United States	08012
2	Rutgers Physical Therapy Program	Newark	New Jersey	United States	07101

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• Thomas Jefferson University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Kietrys, Associate Professor, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT04889521
• Other Study ID Numbers: Pro2020003234(cross-sec)
• First Posted: May 17, 2021
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by David Kietrys, Associate Professor, Rutgers, The State University of New Jersey: peripheral neuropathy; pain; function
• Additional relevant MeSH terms: HIV Infections

Study Results

No Results Posted as of Jul 28, 2022