Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Gait - Step Length
研究概览
简要总结
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •current opportunistic infection(s)
- •cluster of differentiation 4 cell (CD4 cell) count <200 cells/mm3
- •uncontrolled psychiatric disorder
- •wounds or sores on the feet
- •musculoskeletal or neurological conditions (other than distal sensory neuropathy) that may affect gait
- •pregnancy
结局指标
主要结局
Gait - Step Length
时间窗: Week 0 (one-time)
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Stride Width
时间窗: Week 0 (one-time)
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Foot Fall Area
时间窗: Week 0 (one-time)
Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway
Gait - Cadence
时间窗: Week 0 (one-time)
Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway
Physical Performance
时间窗: 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
时间窗: Week 0 (one-time)
Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway
Gait - Step Time
时间窗: Week 0 (one-time)
Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway
次要结局
- 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)
研究者
David Kietrys
Associate Professor
Rutgers, The State University of New Jersey