Dual-Task Cost During Walking in People With Hearing Loss Compared to Normal Hearing
Conditions: Bilateral Hearing Loss, Healthy Aging
Sponsor: New York University

 
 
 
 
 
 
 
 
Dual Task Walking Performance in Adults with 
Bilateral Hearing Loss Compared to 
Adults with Normal Hearing 
 
NCT05540535 
 
08/30/2022 
 
 
 

PROTOCOL PILOT STUDY:                                                            
1. Sign COVID screening at the lobby 
2. SIGN CONSENT  
3. ETDRS- eyes check (screening) 
4. MONOFILAMENT TEST- put the shoes on (screening) 
5. Vestibular examination: (screening)- Dizziness Handicap Inventory (DHI) questionnaire 
(in REDCAP) 
6. Auditory screening for the control group )screening older controls for ARHL rather than a 
full audiogram to everyone). 
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Exclusion due to one of the followings: 
• 
ETDRS - visual impairment above 20/63 
• MONOFILAMENT - No protective sensation at the bottom of their feet. 
• DHI- Participants will be included with a score of 10 or below indicating no more 
than minimal dizziness. 
• Auditory screening – participants in the control group that will exhibit a PTA higher 
than 40 dB (0.5–4 kHz) in the better ear (moderate HL and above) will be excluded. 
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7. TAKE OFF HEARING AID 
8. Wearing the APDM on both feet and pelvic where the ISPS 
9. Balance testing: Standing feet attached with E/O, Standing feet attached with E/C, foam 
with E/O, foam with E/C for 30 sec. (descriptive) 
10. 20 min: computerized cognitive battery  
11. Randomized Trial of TUG (without hearing aid):  
1. TUG - 2 repetitions 
2. TUG DT_sub3- 2 repetitions  
12. HI- MOCA or MOCA  
13. TMT A & B 
14. Practice trial: Walking back and forth the corridor  

15. Randomized Trial- each trial will be done 1 time (without hearing aid):  
1. Single cognitive task sub1 - [Baseline] while sitting (serial substruction of 1) + record 
with phone 
2. Single cognitive task sub3 - [Baseline] while sitting (serial substruction of 3) + record 
with phone 
3. Single motor – [Baseline] Walking on the ground for 1 min a 10 m long corridor – 
recording with a stopwatch 
4. Dual task cognitive sub1 (DT_ sub1) - serial substruction of 1 + #3 - recorded with stopwatch 
+ record with phone  
5. Dual task cognitive sub3 (DT_ sub3) - serial substruction of 3 + #3 - recorded with stopwatch 
+ record with phone 
Using REDCAP: 
16. DEMOGRAPHIC questionnaire (descriptive) 
17. ABC – In healthy young adults ask: “have you never had any concern regarding: balance?” 
– if yes- fill up the questionnaire. (descriptive) 
18. SSQ12 
19. Each participant will receive $20 for participation and sign up a form that received the gift card 
 
 
Instructions: 
TUG: 
Instructions: “On the word GO you will stand up, walk to the line on the floor, turn around and 
walk back to the chair and sit down. Walk at your regular pace.” 
The time to complete the test will be recorded using a stopwatch.  
 
DT SUB 1 TUG: 
Instructions: “On the word GO you will stand up, walk to the line on the floor, turn around and 
walk back to the chair and sit down. Walk at your regular pace. While walking you need to subtract 
1 from a number that I will tell you (between 20 -100)” 

 
DT SUB 3 TUG: 
Instructions: “On the word GO you will stand up, walk to the line on the floor, turn around and 
walk back to the chair and sit down. Walk at your regular pace. While walking you need to subtract 
3 from a number that I will tell you (between 20 -100)” 
 
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In DT cognitive TUG individuals will be asked to complete the walk while performing a cognitive 
task (counting backward by threes from any number between 20 to 100). The cut off times using 
DT TUG to discriminate between fallers and non-fallers in elderly is >15 seconds with an overall 
correct prediction rate of 87%. 
Gait: 
“Walk straight ahead at your comfortable speed until you see the mark on the floor and then turn 
and walk straight ahead to the opposite direction. Keep walking until I will tell you to stop. The 
total time for walking is 1 min. If you lose your balance do whatever feels safe to stay steady. One 
of the researchers is going to walk next to you to prevent any fall”. 
 
Gait Serial Subtraction 1 
“Walk straight ahead at your comfortable speed while counting backwards out loud in jumps of 1 
from a number that I will tell. Start from the next number. For example, if I say 557, you start: 
556, 555 and so on. When you see the mark on the floor you turn and walk straight ahead to the 
opposite direction. Keep walking and counting until I will tell you to stop. The total time for 
walking is 1 min. If you lose your balance do whatever feels safe to stay steady. One of the 
researchers is going to walk next to you to prevent any fall”. 
 
Gait Serial Subtraction 3 
“Walk straight ahead at your comfortable speed while counting backwards out loud in jumps of 1 
from a number that I will tell. Start from the next number. For example, if I say 557, you start: 
554, 551 and so on. When you see the mark on the floor you turn and walk straight ahead to the 

opposite direction. Keep walking and counting until I will tell you to stop. The total time for 
walking is 1 min. If you lose your balance do whatever feels safe to stay steady. One of the 
researchers is going to walk next to you to prevent any fall”. 
 
Data analysis:  
Each variable was inspected for extreme outliers (i.e., data points that fell more than 4 standard 
deviations [SD] away from the mean) using summary statistics and box plots. An extreme outlier 
was excluded from the final analysis. Normality of the variables was determined based on 
skewness and kurtosis. Number that is greater than +1 or lower than –1 indicate a substantially 
skewed distribution. For kurtosis, if the number is greater than +1, the distribution is too peaked 
and less than –1 indicates a distribution that is too flat. If the distribution was found to deviate 
from normality, non-parametric statistical analysis was conducted.  
Descriptive statistics described the study sample for age, sex, height, weight, race, current 
medication, education level, exercise level, DHI, ABC, history of falls, MoCA and HI- MoCA. To 
determine if the groups are similar with respect to background measures and demographics a 
comparison of the three groups Normal hearing, Mild BHL and > Moderate BHL (moderate, 
moderately-severe, severe and profound) was done using one-way analysis of variance (ANOVA) 
or non-parametric Kruskal-Wallis Test for continuous measures and Chi-square analyses for 
categorical measures (e.g., gender).  
For Aim #1: Compare single task (=ST) gait parameters between individuals age and education-
matched with Mild BHL, > Moderate BHL and controls with Normal hearing and Aim #3: 
Compare the effect of a cognitive task on gait parameters (=DT) between age and education-
matched people with Mild BHL, > Moderate BHL and control with Normal hearing: For the 
primary outcome measure, gait speed and its variability, and secondary outcome measures (stride 
length, stride time and their variability) during the 1-min walk, a mixed model repeated measures 
(RM)- ANOVA was conducted with 1 within-factor (task) of 2 levels (ST and DT [‘subtraction 
3’]) and 1 between factor (group) of 3 levels (Normal hearing, Mild BHL, Moderate BHL). When 
the distributions were found to deviate from normality the Kruskal-Wallis’ test was conducted for 
a between-group comparison and the Wilcoxon signed-rank test for a within-group  
comparison. Since I had a significant difference with age, I adjusted for age the ANOVA 
comparison.  

Partial Eta Square (PET) Effect Size was reported for each main effect and interaction (small 
effect, PET ≥ 0.08; middle effect, PET ≥ 0.20; and high effect, PET ≥ 0.32). P-values with a value 
of p<0.05 were considered statistically significant. Bonferroni corrections were applied to post hoc 
comparisons as applicable.  
For Aim #2: Compare cognitive function (i.e., the Neurocognitive Index) between individuals age 
and education-matched with Mild BHL, > Moderate BHL and controls with Normal hearing. One 
way ANOVA (or non-parametric Kruskal-Wallis Test) was used to compare the Neurocognitive 
Index between the three groups. Moreover, one way ANOVA (or non-parametric Kruskal-Wallis 
Test) was used to compare the secondary outcome measures, i.e., Composite Memory, Verbal 
Memory, Visual Memory, EF, Cognitive Flexibility, Complex RT, Working Memory and 
Sustained Attention and the cognitive ST and DT performance. I used one-way ANOVA with the 
dependent variable, the cognitive domain (Neurocognitive Index or any of the secondary outcome 
measures), and group as independent variable. For the raw scores I used the ACNOVA to adjust 
for age since we had significant age difference and these results do not present an age-matched 
score. Cohen’s d effect size was calculated per comparison and was defined 'small' effect size as d 
= 0.2, 'medium' effect size as d= 0.5 and a 'large' effect size as d= 0.8. 
For Aim #4: Explore whether cognitive performance (i.e., the Neurocognitive Index) is correlated 
with DTC per group. One way ANOVA (or non-parametric Kruskal-Wallis Test) was used to 
compare the DTC between the three groups. Correlations between the cognitive domains and DTC 
were assessed using Pearson’s correlation (or its non-parametric equivalent Spearman’s, if the 
distributions are found to deviate from normality) for continuous variables. Pearson’s correlation 
for each comparison was defined as ‘little to none’ for r = 0-0.24, ‘fair’ for r = 0.25-0.49, ‘moderate 
to good’ for r= 0.50-0.74 and ‘good to excellent’ for r= 0.75-1.00.112 SPSS version 27 IBM (NY, 
US) was used for all statistical analysis.