Neuropathy Walks (Cross-sectional)
- Conditions
- HIV Infections
- Interventions
- Other: No intervention
- Registration Number
- NCT04889521
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description HIV and painful neuropathy No intervention Persons living with HIV who also have painful distal sensory polyneuropathy in the feet. HIV without painful neuropathy No intervention Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet.
- Primary Outcome Measures
Name Time Method Gait - Step Length Week 0 (one-time) Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Stride Width Week 0 (one-time) Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Foot Fall Area Week 0 (one-time) Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway
Gait - Cadence Week 0 (one-time) Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway
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
Gait - Walking velocity Week 0 (one-time) Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway
Gait - Step Time Week 0 (one-time) Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway
- Secondary Outcome Measures
Name Time Method Walking Endurance Week 0 (one-time) Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
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.
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
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
Trial Locations
- Locations (1)
Rutgers Physical Therapy Program
🇺🇸Newark, New Jersey, United States