CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
Gait assessment +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05540535
NCT05540535N/ACompleted

Dual-Task Cost During Walking in People With Hearing Loss Compared to Normal Hearing

New York University·observational·Posted Sep 14, 2022·Updated Jan 13, 2025

In Brief

An observational study evaluating Gait assessment and Cognitive assessment for Bilateral Hearing Loss and Healthy Aging. Completed, enrolled 67 participants across 2 sites.

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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedSep 14, 2022
Enrollment StartFeb 1, 2022
Primary CompletionSep 30, 2023
Study CompletionNov 22, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.8 years ago

Interventions

Gait assessmentother

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.

Cognitive assessmentother

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.