NCT03446677

Brief Summary

Persons with HIV can present vestibular system impairments, affecting postural stability. There is scarce literature related to the contribution of the visual and somatosensory systems in maintaining postural stability in persons with HIV. The purpose of this study is to describe the sensory systems used to maintain postural stability and how the sources of sensory information contributes to postural stability in asymptomatic persons with HIV. Postural stability was measured in 20 asymptomatic persons with HIV (11 male, 9 female, aged 43 ± 8 years). Static postural stability was evaluated during eight conditions that perturbed the visual, somatosensory and vestibular inputs. A paired-samples t-test was conducted to compare center of pressure (COP), antero-posterior displacement (APD) and right-left displacement (RLD) on stable and unstable surface and to characterize each balance sensory system. There was a significant difference in the COP and APD of eyes open condition compared to the remaining conditions on stable surface. Furthermore, there was a significant difference in the COP, APD and RLD for the eyes open on a foam surface compared to the remaining conditions on an unstable surface. Postural instability can be detected in asymptomatic persons with HIV under challenging conditions, previous to the evident appearance of balance impairments.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 11, 2018

Last Update Submit

February 20, 2018

Conditions

Keywords

HIVBalanceVestibularSomatosensorypostural stabilitycenter of pressure

Outcome Measures

Primary Outcomes (1)

  • Postural Stability

    Postural stability was operationally defined by the center of pressure displacement measured by the MatScan® pressure mat. These sensors detect the displacement as the body sways anterior, posterior or laterally (right or left).

    Baseline

Study Arms (1)

Asymptomatic persons with HIV

EXPERIMENTAL
Other: Postural Stability Testing

Interventions

Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks. Data of center of pressure, antero-posterior sways and medial-lateral sways were collected in each of the conditions. Each task took 30 seconds to be performed. The first 4 tasks were performed with the mat on the hard surface of the floor. These 4 tasks are as follows: standing with eyes open, standing with eyes closed, standing with eyes open looking and actively moving head upward and downward, and standing with eyes closed and the head actively moving upward and downward. The subjects were asked to perform four more tasks while standing on a thick piece of balance foam that was placed on top of the MatScan®. The remaining 4 tasks are as follows: standing with eyes open, standing with eyes closed, standing with eyes open looking and actively moving the head upward and downward, and standing with eyes closed with head actively moving upward and downward.

Asymptomatic persons with HIV

Eligibility Criteria

Age25 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CD4 levels above 300,
  • age within the range of 25-57 years
  • walks without assistive device
  • tolerates standing position for at least 30 minutes
  • stable cardiorespiratory system.

You may not qualify if:

  • diagnosis of AIDS (CD4 levels less than 200)
  • diagnosis of Diabetes, Dementia or Arthritis
  • severe neuropathy
  • severe balance impairments
  • severe visual acuity problems that are not treated
  • BMI \> 40,
  • decreased functional strength in the lower extremities
  • severe proprioception impairments
  • falls during the last 6 months
  • back or lower extremities lesion or surgery during the last 6 months
  • the use of medications that causes drowsiness 24 hours previous to intervention
  • women that are pregnant or think they might be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (21)

  • Sullivan EV, Rosenbloom MJ, Rohlfing T, Kemper CA, Deresinski S, Pfefferbaum A. Pontocerebellar contribution to postural instability and psychomotor slowing in HIV infection without dementia. Brain Imaging Behav. 2011 Mar;5(1):12-24. doi: 10.1007/s11682-010-9107-y.

    PMID: 20872291BACKGROUND
  • Heinze BM, Vinck BM, Hofmeyr LM, Swanepoel de W. Vestibular involvement in adults with HIV/AIDS. Auris Nasus Larynx. 2014 Apr;41(2):160-8. doi: 10.1016/j.anl.2013.08.003. Epub 2013 Oct 19.

    PMID: 24145102BACKGROUND
  • Cohen HS, Cox C, Springer G, Hoffman HJ, Young MA, Margolick JB, Plankey MW. Prevalence of abnormalities in vestibular function and balance among HIV-seropositive and HIV-seronegative women and men. PLoS One. 2012;7(5):e38419. doi: 10.1371/journal.pone.0038419. Epub 2012 May 31.

    PMID: 22675462BACKGROUND
  • Heinze B, Swanepoel DW, Hofmeyr LM. Systematic review of vestibular disorders related to human immunodeficiency virus and acquired immunodeficiency syndrome. J Laryngol Otol. 2011 Sep;125(9):881-90. doi: 10.1017/S0022215111001423. Epub 2011 Jul 5.

    PMID: 21729430BACKGROUND
  • Shumway-Cook A, Woollacott M. (2012). Normal Postural Control. In: Motor Control Translating Research into Clinical Practice. 4th ed. Baltimore, MD: Lippincott Williams & Wilkins;:

    BACKGROUND
  • Ruhe A, Fejer R, Walker B. The test-retest reliability of centre of pressure measures in bipedal static task conditions--a systematic review of the literature. Gait Posture. 2010 Oct;32(4):436-45. doi: 10.1016/j.gaitpost.2010.09.012. Epub 2010 Oct 13.

    PMID: 20947353BACKGROUND
  • Dellepiane M, Medicina MC, Mora R, Salami A. Static and dynamic posturography in patients with asymptomatic HIV-1 infection and AIDS. Acta Otorhinolaryngol Ital. 2005 Dec;25(6):353-8.

    PMID: 16749603BACKGROUND
  • Teggi R, Giordano L, Pistorio V, Bussi M. Vestibular function in HIV patients: preliminary report. Acta Otorhinolaryngol Ital. 2006 Jun;26(3):140-6.

    PMID: 17063983BACKGROUND
  • Rosario M, Ortiz A. Balance assessment in people with HIV. Paper presented at: 60th Annual Meeting of American College of Sports Medicine (ACSM)

    BACKGROUND
  • Adamo DE, Pociask FD, Goldberg A. The contribution of head position, standing surface and vision to postural control in young adults. J Vestib Res. 2013;23(1):33-40. doi: 10.3233/VES-130473.

    PMID: 23549053BACKGROUND
  • Duffy JC, Patout CA Jr. Management of the insensitive foot in diabetes: lessons learned from Hansen's disease. Mil Med. 1990 Dec;155(12):575-9.

    PMID: 2125335BACKGROUND
  • Bell-Krotoski J, Weinstein S, Weinstein C. Testing sensibility, including touch-pressure, two-point discrimination, point localization, and vibration. J Hand Ther. 1993 Apr-Jun;6(2):114-23. doi: 10.1016/s0894-1130(12)80292-4.

    PMID: 8393725BACKGROUND
  • FUKUDA T. The stepping test: two phases of the labyrinthine reflex. Acta Otolaryngol. 1959 Mar-Apr;50(2):95-108. doi: 10.3109/00016485909129172. No abstract available.

    PMID: 13636842BACKGROUND
  • Whitney SL, Wrisley DM, Marchetti GF, Gee MA, Redfern MS, Furman JM. Clinical measurement of sit-to-stand performance in people with balance disorders: validity of data for the Five-Times-Sit-to-Stand Test. Phys Ther. 2005 Oct;85(10):1034-45.

    PMID: 16180952BACKGROUND
  • Chui K, Schmitz T. (2007). Examination of sensory function. In: O'Sullivan S, Schmitz T. Physical Rehabilitation.

    BACKGROUND
  • Heinze BM, Vinck BM, Swanepoel DW. Does the human immunodeficiency virus influence the vestibulocollic reflex pathways? A comparative study. J Laryngol Otol. 2014 Sep;128(9):772-9. doi: 10.1017/S0022215114001996. Epub 2014 Aug 28.

    PMID: 25166876BACKGROUND
  • O'Sullivan SB. (2007). Examination of Motor Function: Motor Control and Motor Learning. In: O'Sullivan SB. Physical Rehabilitation. 5th ed. Philadelphia

    BACKGROUND
  • Creath R, Kiemel T, Horak F, Peterka R, Jeka J. A unified view of quiet and perturbed stance: simultaneous co-existing excitable modes. Neurosci Lett. 2005 Mar 29;377(2):75-80. doi: 10.1016/j.neulet.2004.11.071. Epub 2004 Dec 19.

    PMID: 15740840BACKGROUND
  • Trenkwalder C, Straube A, Paulus W, Krafczyk S, Schielke E, Einhaupl KM. Postural imbalance: an early sign in HIV-1 infected patients. Eur Arch Psychiatry Clin Neurosci. 1992;241(5):267-72. doi: 10.1007/BF02195975.

    PMID: 1606190BACKGROUND
  • Sarlegna FR, Malfait N, Bringoux L, Bourdin C, Vercher JL. Force-field adaptation without proprioception: can vision be used to model limb dynamics? Neuropsychologia. 2010 Jan;48(1):60-7. doi: 10.1016/j.neuropsychologia.2009.08.011.

    PMID: 19695273BACKGROUND
  • Cameron M, Monroe L. (2007). Balance and fall risk. In: Tyner T, Allen D. Physical Rehabilitation Evidence-Based Examination, Evaluation, and Intervention. San Louis, Missouri: Saunders. 300-332

    BACKGROUND

Related Links

MeSH Terms

Conditions

Vestibular DiseasesSomatosensory Disorders

Condition Hierarchy (Ancestors)

Labyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Martin G Rosario, Ph.D

    Texas Woman's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 11, 2018

First Posted

February 27, 2018

Study Start

July 22, 2014

Primary Completion

May 22, 2015

Study Completion

July 22, 2015

Last Updated

February 27, 2018

Record last verified: 2018-02