An interventional study of Postural Stability Testing in HIV, Balance and Vestibular Disorder, sponsored by Texas Woman's University. Completed. Open to participants aged 25 Years to 57 Years. Per ClinicalTrials.gov, last updated 2018-02-27.
Sponsored by Texas Woman's University · Not applicable, Interventional, and Screening
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.
The institutional review boards (IRB) of the University of Puerto Rico Medical Science Campus, reviewed and approved this study before any data collection was initiated. An informed consent was provided to each subject to access their medical records, HIV status, CD4+ cell count and as a requirement to participate in the study.
The subjects were recruited from La Perla de Gran Precio (Community wellness center that specializes in individuals with HIV) localized in San Juan, Puerto Rico. Each subject was evaluated by interview and review of their medical record for the inclusion and exclusion criteria assessment. Different tests were performed as a screening tool to identify additional limitations or impairments in the different sensory systems. To rule out severe neuropathy, the subject had to be able to detect a Semmes- Weinstein Monofilament of 5.07 or less in more than two areas of the foot.12,13 The visual system was screened using Snellen chart and the subject had to obtain at least 20/40 of visual acuity. To rule out severe balance impairments, the Romberg Test and Fukuda's Stepping Test were used. For Romberg Test, subjects had to maintain standing position for 30 seconds and Fukuda's Stepping Test required that the subject did not rotate more than 30° from the initial position or deviate more than 0.5 meters from the center of the circle. Functional strength of lower extremities was screened using a Five Times Sit to Stand test, where the subject had to complete the test in 10 seconds or less. Severe proprioception impairments were assessed using a Proprioceptive Awareness test, where the subject was asked to replicate the initial position performed by the evaluator in the contralateral ankle joint in three trials. After the screening of the inclusion and exclusion criteria, a total of 20 subjects were able to participate in the study.
Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed eight 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 four tasks were performed with the mat on the hard surface of the floor. These four tasks are as follows:1) eyes open looking at a fixed point to evaluate all systems (EO); 2) eyes closed (with head fixed approximately 90˚) to eliminate visual input (EC); 3) eyes open looking at a fixed point and actively moving head upward and downward to alter vestibular inputs (EO+HUD). The subject was instructed to maintain a movement frequency of 60bpm and amplitude of approximately 45 degrees in each direction: neck flexion and extension; 4) eyes closed (with head fixed approximately 90˚) to eliminate visual input and the head actively moves upward and downward to alter vestibular inputs (EC+HUD). The subject is instructed to maintain the movement frequency and amplitude as described in task 3.
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®, creating an unstable surface. The remaining four tasks (tasks 5-8) are as follows: 5) eyes open looking at a fixed point while standing on the balance foam to alter somatosensory inputs (EO+BF); 6) eyes closed with head fixed approximately 90˚ while standing on the balance foam to alter somatosensory inputs and eliminate visual inputs (EC+BF); 7) eyes open looking at a fixed point and actively moving the head upward and downward while standing on the balance foam to alter somatosensory and vestibular inputs (EO+HUD+BF). The subject was instructed to maintain the movement frequency and amplitude as described in task 3; 8) eyes closed with head fixed approximately 90˚ and actively move head upward and downward while standing on the balance foam to eliminate visual inputs and alter somatosensory and vestibular inputs (EC+HUD+BF). The subject is instructed to maintain the movement frequency and amplitude as described in task 3.
Data of postural stability was obtained using the MatScan® pressure mat (TekScan, Boston, MA). The data collected from the pressure mat was analyzed with Tekscan Sway Analysis Module™ (SAM) software (TekScan, Boston, MA) designed for this purpose. Mean and standard deviation were used to describe data. The statistical software used was SPSS-20 to perform a Paired-Samples t-test and compare the center of pressure, antero-posterior and right-left body sways displacement. P values \<0.05 were accepted as statistically significant.
170 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 127 interventional studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Texas Woman's University is the lead sponsor of 84 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Postural Stability Testing
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.
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).
Time frame: Baseline
No study locations are listed for this record.
Ran from Jul 2014 to primary completion in May 2015, 10 months.
Of 79 non-industry interventional studies with no phase under Vestibular Diseases, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 10 months is below that.
Counting every sponsor, half of 84 studies reached it within 15 months; a quarter within 8 and three quarters within 34.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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