NCT05540535

Dual-Task Cost in Bilateral Hearing Loss

Completed Results posted Last updated 13 January 2025

What this trial tests

trial testing Gait assessment in Bilateral Hearing Loss in 67 participants. Completed in 22 November 2024.

Timeline

1 February 2022

Primary endpoint
30 September 2023

22 November 2024

Quick facts

Lead sponsor	New York University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	67
Start date	1 February 2022
Primary completion	30 September 2023
Estimated completion	22 November 2024
Sites	2 locations across United States

Drugs / interventions tested

• Gait assessment
• Cognitive assessment

Conditions studied

• Bilateral Hearing Loss — all drugs for Bilateral Hearing Loss →
• Healthy Aging — all drugs for Healthy Aging →

Sponsor

New York University

Who can join

40 and older, any sex, with Bilateral Hearing Loss or Healthy Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Gait Speed (Single Task) Over 1-minute Walk Primary · 60 seconds of a walk.

The gait speed while walking for 1 min will be compared between groups. Normal gait speed will be considered 1.2-1.3 m/sec.

Group	Value	95% CI
Control Participants With Normal Hearing.	1.14	± 0.15
Mild Bilateral Symmetrical Hearing Loss	1.02	± 0.21
>Moderate Bilateral Symmetrical Hearing Loss	1.1	± 0.10

The Neurocognitive Index Primary · 30 minutes of assessment.

The Neurocognitive Index is the average of standardised scores obtained out of six cognitive sub-domains: Composite Memory, Reaction Time, Cognitive Flexibility, Executive Function, Working Memory and Sustained Attention, representing a form of a global score of the overall neurocognitive status of the subject. The range of the six cognitive sub-domains standardised scores and of the Neurocognitive Index is: below 70 which counts as very low score and above 110 which counts as an above averge score. Higher scores are better. Standard Scores are normalized from raw scores and present an age mat

Group	Value	95% CI
Control Participants With Normal Hearing.	105.45	± 7.62
Mild Bilateral Symmetrical Hearing Loss	108.15	± 5.70
>Modertae Bilateral Symmetrical Hearing Loss	107.05	± 5.52

Gait Speed (Dual Task {DT}) Over 1-minute Walk Primary · 60 seconds of a walk.

To test allocation of attention during walking using DT paradigm the DT gait speed while walking for 1 min and performing a cognitive task which was serial subtraction (counting backwards out loud) in jumps of 3 from a random three-digit number was compared between groups.

Group	Value	95% CI
Control Participants With Normal Hearing.	0.95	± 0.20
Mild Bilateral Symmetrical Hearing Loss	0.84	± 0.19
> Modearte Bilateral Symmetrical Hearing Loss	0.90	± 0.10

Single and Dual Task Stride Length Secondary · 60 seconds of a walk.

Stride length while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the distance between two successive placements of the same foot. It consists of two step lengths, left and right.It was measured in meters (m).

Single Task stride length

Group	Value	95% CI
Normal Hearing	1.26	± 0.13
Mild Bilateral Hearing Loss	1.14	± 0.17
> Moderate Bilateral Hearing Loss	1.20	± 0.12

Dual Task stride length

Group	Value	95% CI
Normal Hearing	1.15	± 0.17
Mild Bilateral Hearing Loss	1.02	± 0.16
> Moderate Bilateral Hearing Loss	1.09	± 0.13

Single and Dual Task Stride Time Secondary · 60 second of a walk

Stride time while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the time from initial contact to the next initial contact of the same foot. It was measured in seconds.

Single Task Stride time

Group	Value	95% CI
Normal Hearing	1.10	± 0.10
Mild BHL	1.14	± 0.10
>Moderate BHL	1.09	± 0.06

Dual Task Stride time

Group	Value	95% CI
Normal Hearing	1.23	± 0.15
Mild BHL	1.24	± 0.13
>Moderate BHL	1.21	± 0.12

Single and Dual Task Stride Length Variability Secondary · 60 second of walking

Variability of stride length is the stride-to-stride fluctuations in walking or "gait unsteadiness"; "a measure of inconsistency and arrhythmicity of stepping". Stride Length Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean).

Single Task Stride Length Variability

Group	Value	95% CI
Normal Hearing	3.24	± 1.09
Mild BHL	3.60	± 1.23
>Moderate BHL	3.79	± 0.84

Dual Task Stride Length Variability

Group	Value	95% CI
Normal Hearing	3.94	± 1.27
Mild BHL	4.96	± 1.62
>Moderate BHL	3.89	± 0.95

Single and Dual Task Stride Time Variability Secondary · 60 second of walking

Variability of stride time is the stride-to-stride fluctuations in walking or "gait unsteadiness"; "a measure of inconsistency and arrhythmicity of stepping". Stride Time Variability while walking for one minute (single task) and while walking and counting backwards subtracting 3 from a 3 digit number (Dual task) was measures as the coefficient of variation (CV) which is a measure of the relative variability. It was calculated as the ratio of the standard deviation to the mean. The formula to calculate that is the following: CV = 100 X (standard deviation/mean).

Single Task Stride Time Variability

Group	Value	95% CI
Normal Hearing	2.07	± 0.56
Mild BHL	2.37	± 0.71
>Moderate BHL	2.31	± 0.62

Dual Task Stride Time Variability

Group	Value	95% CI
Normal Hearing	3.34	± 1.17
Mild BHL	3.59	± 0.12
>Moderate BHL	3.60	± 1.33

Sponsor's own description

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 \[(DT - single task)/ single task\].

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.