HIV InfectionsNCT04889521
Neuropathy Walks (Cross-sectional)
An observational study of HIV Infections, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- HIV Infections
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2022to 13 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons living with HIV. Half of sample will include concurrent painful distal sensory neuropathy in the feet.
Who may be able to join
- 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:
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rutgers Physical Therapy Program
Blackwood, New Jersey, 08012
Rutgers Physical Therapy Program
Newark, New Jersey, 07101
About this study
Official title: Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV
Cross-sectional study is to explore the impact of painful neuropathy in the feet on function in persons living with HIV (PLHIV).
Read the 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.
- Conditions
- HIV Infections
- Being tested
- No intervention
- Keywords
- peripheral neuropathy, pain, function
- Medical subject headings
- HIV Infections, Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention. Study is cross-sectional observational.
| Study group | Role | What they receive |
|---|---|---|
| HIV and painful neuropathy | Persons living with HIV who also have painful distal sensory polyneuropathy in the feet. Receives: Other: No intervention | |
| HIV without painful neuropathy | Persons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait - Walking velocity
Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway
Measured: Week 0 (one-time)
Gait - Step Length
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Measured: Week 0 (one-time)
Gait - Step Time
Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway
Measured: Week 0 (one-time)
Gait - Stride Width
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Measured: Week 0 (one-time)
Gait - Cadence
Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway
Measured: Week 0 (one-time)
Gait - Foot Fall Area
Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway
Measured: 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
Measured: Week 0 (one-time)
Secondary outcomes (4)
Walking Endurance
Walking endurance as measured with the 6-Minute Walk test (distance walked over span of 6 minutes).
Measured: 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.
Measured: 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
Measured: 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
Measured: 5 days from date of all other outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start22 Apr 2022
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, David Kietrys, Rutgers, The State University of New Jersey
- Investigators
- David Kietrys, PhD, Principal investigator, Rutgers School of Health Professions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889521
- Sponsor's protocol ID
- Pro2020003234(cross-sec)
- Status last verified
- Mar 2025
- First submitted
- 11 May 2021
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Distal Sensory Polyneuropathy on Function in Persons Living With HIV
- ClinicalTrials.gov ID
- NCT04889521
- Acronym / sponsor ID
- Pro2020003234(cross-sec)
- Conditions
- HIV Infections
- Keywords
- peripheral neuropathy, pain, function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV and painful neuropathy | – | Other: No interventionPersons living with HIV who also have painful distal sensory polyneuropathy in the feet. |
| HIV without painful neuropathy | – | Other: No interventionPersons living with HIV who do NOT have painful distal sensory polyneuropathy in the feet. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons living with HIV. Half of sample will include concurrent painful distal sensory neuropathy in the feet.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention. Study is cross-sectional observational. | Other | HIV and painful neuropathy, HIV without painful neuropathy |
Primary outcome
Gait - Walking velocity
Time frame: Week 0 (one-time)
Temporal characteristic of gait measured in m/sec as captured with a ZENO instrumented walkway
Gait - Step Length
Time frame: Week 0 (one-time)
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Step Time
Time frame: Week 0 (one-time)
Temporal characteristic of gait measure in seconds as captured with a ZENO instrumented walkway
Gait - Stride Width
Time frame: Week 0 (one-time)
Spatial characteristic of gait measured in meters as captured with a ZENO instrumented walkway
Gait - Cadence
Time frame: Week 0 (one-time)
Temporal characteristic of gait measured in steps per minute as captured with a ZENO instrumented walkway
Gait - Foot Fall Area
Time frame: Week 0 (one-time)
Spatial characteristic of gait measured in square meters as captured with a ZENO instrumented walkway
Physical Performance
Time frame: 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
4 secondary outcomes
Walking Endurance
Time frame: Week 0 (one-time)
Whole Body Strength
Time frame: Week 0 (one-time)
Pain pressure threshold
Time frame: Week 0 (one-time)
Physical Activity
Time frame: 5 days from date of all other outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Kietrys, PhD principal investigator
Rutgers School of Health Professions
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait - Walking velocity (time frame: Week 0 (one-time)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.