Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05540535 |
Other study ID # |
STUDY-21-01026 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
May 30, 2024 |
Study information
Verified date |
November 2023 |
Source |
New York University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The specific aims of the research study are:
1. Compare single-task gait parameters between individuals with hearing loss (HL) and age
and education matched controls with normal hearing [normal vs moderate-profound hearing
loss (N=23 for each group)]. For that we will compare the primary outcome measure, gait
speed, between the groups while participants are walking at a comfortable speed for 1
minute.
2. Compare cognitive function between individuals with HL and age and education matched
controls. For that we will compare the Neurocognitive Index, derived from a cognitive
assessment between groups.
3. Compare the effect of a cognitive task while walking on gait parameters between people
with HL and age education matched controls with normal hearing. For that we will compare
the primary outcome measure, gait speed, between groups while participants are walking
at a comfortable speed and counting backwards [serial subtraction of 3] for 1 minute.
4. Explore whether cognitive performance (i.e., the Neurocognitive Index) is correlated
with Dual task cost (DTC), a deterioration of gait speed while walking and performing
concurrent cognitive task [serial subtraction of 3]. The formula to calculate this is
the following: DTC = 100 X [(DT - single task)/ single task].
Description:
Procedure and Data Collection:
Participants will be tested at the NYU Physical Therapy department (380 2nd Ave 3rd and 4th
floors). Data will be collected by the main researcher who proposes this research work and/or
two other lab researchers who are trained to conduct the full protocol. Testing will take
between 1.5 to 2 hours and will always start with the cognitive assessment in order to make
sure participants will perform at their best and will not be fatigued. All participants will
sign an informed consent form. Participates with HL will be tested without hearing aids since
recent studies suggest a possible improvement in balance as well as cognition with
amplification. Participates will take off their hearing aid at the beginning of testing.
Screening Examination and Descriptive Measures of participants:
The participants will undergo a sensory systems screen including: Early Treatment Diabetic
Retinopathy Study (ETDRS) chart confirming normal vision and a 5.07 monofilament screen
confirming normal protective sensation at the bottom of their feet. The screening for the
vestibular system will include the Dizziness Handicap Inventory (DHI) questionnaire.
Screening of the auditory system will be done in participants with HL (as part of their
standard care) and for healthy controls who are 60 years of age or older. Participants will
also complete the following questionnaires: a demographics and anthropometrics questionnaire,
and Activities-Specific Balance Confidence (ABC) to assess balance confidence. To assess the
history of falls questions about past falls will be asked. The MoCA will be administered for
people with normal hearing, and the HI-MoCA for people with HL in order to assess mild
cognitive decline. For people with HL, the Speech, Spatial and Qualities of Hearing Scale
(SSQ12), a test assessing function and interference in hearing in daily living, will be
conducted. To assess balance and mobility two tests will be conducted: the modified Clinical
Test of Sensory Interaction on Balance (mCTSIB) and Time Up and Go Test (TUG). First
participants will wear the APDM inertial motion sensors on both feet and waist and will
perform the mCTSIB. They will stand with their hands at their sides, feet together and will
perform the following sensory conditions for 30 sec: (1) Stand on a firm surface with eyes
open, (2) Stand on a firm surface with eyes closed, (3) Stand on a foam with eyes open, and
(4) Stand on a foam with eyes closed. Secondly, participants will perform the TUG twice. The
best performance in each condition out of the 2 performances will be recorded.
Cognitive Assessment:
Participants will complete a computerized cognitive battery (CNS vital sign; CNSVS) that will
include verbal memory, visual memory, Stroop test, shifting attention and 4-part continuous
performance (sustained attention and working memory). Moreover, performance on the single
cognitive task (serial subtraction in jumps of 3; measuring working memory and executive
function) will also be evaluated while sitting (cognitive single task). The numbers will be
recorded for offline processing and the outcome will be the number of correct numbers. These
tests do not require the ability to hear in order to pass successfully. Also, there is a need
for investigation of cognitive domains such as attention, memory, executive function, and
cognitive flexibility in people with HL.
Gait Assessment:
The average speed of gait and spatiotemporal gait parameters would be calculated by the APDM,
inertial motion units. Participants will walk in their normal speed for 1 minute along a
corridor, back and forth, with or without performing a cognitive task (single or DT). The DT
condition will include serial subtraction (counting backwards out loud) in jumps of 3 from a
random three-digit number. Randomization of numbers will be done using the excel function
generating random numbers (Excel RAND function). The numbers will be recorded for offline
processing and the outcome will be the number of correct numbers. Each condition will be
performed once, and all conditions will be randomized.