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临床试验/NCT05418998
NCT05418998已完成不适用

Training Cognition to Improve Mobility and Listening in Older Adults with Hearing Loss: Moving from Lab to Life

Concordia University, Montreal2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年8月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
63
试验地点
2
主要终点
Pre-training Change in stride time (mean, standard deviation [SD] of stride time)

研究概览

简要总结

The proposed study is designed to evaluate the effect of at-home executive function training on cognition and mobility in older adults with age-related hearing loss (ARHL), older adults with normal hearing, and middle-aged adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

盲法说明

The investigator will be blinded to group assignment.

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Proficient in English (learned before age 5), can ambulate ≥ 10 meters independently, absence of cognitive impairment (neuropsychological test results in the average range compared to age norms), normal or corrected-to-normal visual acuity (ETDRS), availability of a home computer or tablet with internet connection.

排除标准

  • Reported major depression, substance abuse or significant psychiatric disorder, uncorrected visual impairment, vestibular impairment, Parkinson's disease or other neurological disorder or sequelae, clinically significant musculoskeletal disorders, diseases affecting the ear, or damage to the ear (e.g., occupational noise), onset of hearing loss prior to adulthood.

结局指标

主要结局

Pre-training Change in stride time (mean, standard deviation [SD] of stride time)

时间窗: baseline

Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

Pre-training Change in auditory 2-back reaction time

时间窗: baseline

Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

Post-training Multi-Talker word perception (accuracy)

时间窗: after 12 weeks

We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

Post-training Change in stride time (mean, standard deviation [SD] of stride time)

时间窗: after 12 weeks

Stride time will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and averaged across the trials. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

Pre-training Change in auditory 2-back accuracy

时间窗: baseline

Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 5, Multi-talker, for other half.

Post-training Change in auditory 2-back reaction time

时间窗: after 12 weeks

Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Reaction time (msec) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

Post-training Change in auditory 2-back accuracy

时间窗: after 12 weeks

Auditory 2-back performance will be assessed under single- and dual-task conditions (i.e., while the participant is standing or simultaneously walking on a treadmill at a self-selected pace). The numbers for the task will be played through binaural speakers, and the decibel level will be individualized for each participant depending on hearing ability. Participants will be required to make a button response indicating whether the number they heard was the same or different from the number they heard two previously. Accuracy (percent correct) will be recorded. Half the participants will be given this assessment. See Outcome 6, Multi-talker, for other half.

Pre-training Multi-Talker word perception (accuracy)

时间窗: baseline

We will use the multi-talker spatial listening task for the other half of the participants, in which a presented text cue indicates which of three simultaneously presented, but spatially distributed spoken sentences to report. Traffic noise will be included to more closely simulate real- world conditions. The signal-to-noise ratio will be held constant across participants, with signal intensity set according to individual average hearing thresholds.

Pre-training Change in stride time variability (mean, standard deviation [SD] of stride time)

时间窗: baseline

Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 5 will perform the same walking task but in a simulated street-crossing environment.

Post-training Change in stride time variability (mean, standard deviation [SD] of stride time)

时间窗: after 12 weeks

Stride time variability will be assessed under single- and dual-task conditions (i.e., walking on a treadmill at a self-selected pace or while simultaneously completing the auditory 2-back task). The spatio-temporal characteristics of gait will be measured by foot pressure sensors worn on the base of the participants' shoes, with one sensor placed beneath the heel and the second sensor placed beneath the toe. The time between successive toe or heel strikes will be recorded (sec) and the standard deviation will be taken to derive a measure of stride time variability. Those participants being assessed with Outcome 6 will perform the same walking task but in a simulated street-crossing environment.

次要结局

  • Post-training Montreal Cognitive Assessment (MoCA)(after 12 weeks)
  • Post-training D-KEFS Stroop(after 12 weeks)
  • Pre-training Rey Auditory Verbal Learning Test(baseline)
  • Post-training WAIS-IV Digit span(after 12 weeks)
  • Pre-training Subjective listening self efficacy(baseline)
  • Post-training Subjective balance confidence(after 12 weeks)
  • Pre-training Montreal Cognitive Assessment (MoCA)(baseline)
  • Pre-training WAIS-IV Digit Symbol Coding(baseline)
  • Post-training WAIS-IV Digit Symbol Coding(after 12 weeks)
  • Pre-training Trail Making Test(baseline)
  • Post-training Trail Making Test(after 12 weeks)
  • Pre-training D-KEFS Stroop(baseline)
  • Post-training Rey Auditory Verbal Learning Test(after 12 weeks)
  • Pre-training Standing Balance (Velocity)(baseline)
  • Pre-training WAIS-IV Digit span(baseline)
  • Post-training Subjective listening self efficacy(after 12 weeks)
  • Pre-training Subjective balance confidence(baseline)
  • Pre-training Mobility functioning as assessed by the Mini BESTest(baseline)
  • Post-training Mobility functioning as assessed by the Mini BESTest(after 12 weeks)
  • Pre-training Standing Balance (Variability)(baseline)
  • Post-training Standing Balance (Path length)(after 12 weeks)
  • Post-training Standing Balance (Velocity)(after 12 weeks)
  • Post-training Standing Balance (Variability)(after 12 weeks)
  • Pre-training Functional neuroimaging (fNIRS)(baseline)
  • Post-training Functional neuroimaging (fNIRS)(after 12 weeks)
  • Pre-training Standing Balance (Path length)(baseline)

研究者

发起方
Concordia University, Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karen Li

Professor

Concordia University, Montreal

研究点 (2)

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