Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
Not provided
Not provided
Not provided
Not provided
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV and painful neuropathy | Persons living with HIV who also have painful distal sensory polyneuropathy in the feet. |
| |
| HIV without painful neuropathy | Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | No intervention. Study is cross-sectional observational. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Walking Endurance | Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes). | Week 0 (one-time) |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Persons living with HIV. Half of sample will include concurrent painful distal sensory neuropathy in the feet.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Kietrys, PhD | Rutgers School of Health Professions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Physical Therapy Program | Blackwood | New Jersey | 08012 | United States | ||
| Rutgers Physical Therapy Program |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2024 | Mar 4, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 2, 2022 | Mar 4, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D010523 | Peripheral Nervous System Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
Not provided
Not provided
Not provided
Not provided
Not provided
| Week 0 (one-time) |
| 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) |
| 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 |
| Newark |
| New Jersey |
| 07101 |
| United States |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |