Responders to Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults

October 13, 2023 updated by: Lou Awad, PT, DPT, PhD, Boston University Charles River Campus

Responders to Metronome-based Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults

Stroke is among the leading causes of long-term disability worldwide. Post-stroke neuromotor impairments are heterogeneous, yet often result in reduced walking ability characterized by slow, asymmetric, and unstable gait patterns. Rhythmic Auditory Stimulation (RAS) is an emerging rehabilitation approach that leverages auditory-motor synchronization to retrain neuromotor control of walking. Indeed, walking with RAS can enhance walking rhythmicity, gait quality, and speed. RAS is a potentially valuable tool for walking rehabilitation after stroke; however, despite extensive research evidence on the overall benefits of RAS in people with chronic stroke, the notable variability in the walking characteristics of individual patients is likely to influence the effectiveness of RAS intervention, and thus requires study. Furthermore, beyond stroke-related factors, age-related changes may also affect how well individuals post-stroke respond to RAS. This study aims to recruit 24 individuals post-stroke and 20 older adults to evaluate the effects of stroke- and age-related neuromotor impairment on RAS intervention. Each study participant will complete two six-minute walk tests: one without RAS (baseline) and the other with RAS delivered using a metronome. The investigators hypothesize that post-stroke individuals will, on average, exhibit a positive response to RAS intervention (i.e., walk farther and with greater gait automaticity (i.e., reduced stride time variability), with the degree of response predicted by specific baseline characteristics. Furthermore, the investigators anticipate that these walking enhancements will be accompanied by improvements in gait biomechanics and a reduction in the metabolic cost of walking. The investigators hypothesize that older adults will exhibit similar, but attenuated, effects of RAS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is among the foremost causes of long-term disability worldwide. Though post-stroke neuromotor impairments are heterogeneous, they often result in reduced walking ability and physical activity, and a slow, asymmetric, and unstable gait. In the chronic phase of stroke, the persistence of walking impairment leads to subsequent declines in walking ability, setting off a cycle of disability and deconditioning, reduced mobility, and increased fall risk. The development and study of interventions that can improve walking ability after stroke has been identified as a top priority among patients, clinicians, and researchers, with the ultimate goal being the enhancement of independence and overall quality of life, and the mitigation of walking-related disability.

Stroke is a disease of aging, and older adults (OA) tend to walk more slowly and with a more variable walking pattern that is energetically more demanding. Similar to stroke survivors, the reduced function and quality of walking in older adults can lead to declines in walking ability, initiating a cycle of disability and deconditioning that increases the risk of injurious falls. Hence, maintaining walking function is crucial for preserving a high quality of life.

Rhythmic Auditory Stimulation (RAS) is a rehabilitation intervention that has shown promise for improving walking in both stroke survivors and older adults. Walking with RAS intervention has been proven to enhance walking function, particularly in terms of walking speed. RAS relies on the innate human capacity to synchronize movements with an external rhythm, such as walking to a regular auditory beat, a process referred to as auditory-motor entrainment. Rhythmic entrainment may stabilize gait patterns and reduce the metabolic cost of walking, as the body naturally selects a walking frequency that maximizes stability and minimizes energy expenditure. Moreover, rhythmic entrainment is thought to reduce the cognitive demand of walking, allowing individuals to allocate their attention to secondary tasks essential for safe community navigation. Despite the evidence supporting its effectiveness in improving walking speed and gait function, the biomechanical changes enabling these improvements are not well understood.

Furthermore, while RAS is an effective intervention, not everyone benefits from it equally. Individuals with stroke present with a wide variety of gait patterns, and the degree of gait impairment may influence the effectiveness of RAS intervention above and beyond any age-related changes. In this study, the investigators aim to identify predictors of the response to RAS intervention. More specifically, they seek to understand the association between baseline walking characteristics and the effect that RAS intervention has on walking ability.

For this analysis, the investigators define responders in three ways: (1) individuals who experience an increase in walking function, (2) individuals who see an improvement in gait quality, or (3) individuals who achieve enhancements in both gait quality and walking function while walking with personalized RAS.

The investigators hypothesize that post-stroke individuals with particular movement characteristics will exhibit increased walking distances and greater automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Given that RAS promotes walking automaticity, the investigators anticipate that individuals with higher walking variability will derive the greatest benefit. Furthermore, investigators hypothesize that older adults with similar movement characteristics will also demonstrate increased walking distances and improved automaticity in the RAS condition compared to the baseline condition; however, it is expected that the effect size will be smaller in comparison to stroke survivors.

The investigators hypothesize that individuals who experience immediate improvements in walking function and/or gait quality while walking with personalized RAS are more likely to respond positively to long-term RAS intervention. However, the mechanism of action enabling this long-term response is expected to differ based on baseline deficits. The short-term, immediate responses to RAS measured in this study may provide insights into potential long-term mechanisms.

Study Protocol:

To assess the varied effects of RAS intervention, each participant will undergo a data collection session involving a series of population-specific clinical tests to characterize a sample of study participants. These tests include the Timed Up and Go (Stroke-specific), Functional Gait Assessment (Stroke-specific), Mini Balance Evaluation System (Older Adults-specific), Short Physical Performance Battery (Older Adults-specific), Mini-Mental State Examination (Older Adults-specific). In addition, all study participants will complete the 10-meter walk test (10MWT) at both a comfortable and fast walking speed and the 6-minute walk test (6MWT). Additionally, the 6MWT will be fully instrumented using motion capture cameras to track retro-reflective markers, wireless inertial measurement units, and force plates embedded in the walkway. These systems will enable simultaneous collection of gait kinematic, inertial, and kinetic signals, respectively. Metabolic measures will also be recorded during the 6MWT using indirect calorimetry.

Following the baseline 6MWT, participants will wear a custom, metronome-based RAS device. This device will employ a metronome application and bone-conducting headphones to provide auditory cues tailored to each participant based on a brief tuning procedure. Subsequently, the 6MWT will be repeated with RAS set to the patient-tailored metronome frequency.

The primary objective of this study is to assess the impact of personalized RAS on walking function (measured as the total distance covered in the 6MWT) and gait quality (evaluated by stride time variability) within each population group (stroke survivors and older adults). The investigators will also analyze RAS-induced changes in secondary gait quality metrics, including (1) the metabolic cost of transport, (2) ground reaction forces during walking, (3) joint kinetics, and (4) spatial-temporal gait parameter changes induced by varying distances. A secondary objective is to determine whether RAS-induced changes in walking function and/or gait quality are linked to specific baseline walking and gait impairment patterns (i.e., movement phenotypes) and whether these movement patterns are influenced by age.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dheepak Arumukhom Revi, MS
  • Phone Number: 6143133081
  • Email: dheepak1@bu.edu

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Boston University Neuromotor Recovery Laboratory
        • Principal Investigator:
          • Louis Awad, PT, DPT, PhD
        • Contact:
          • Dheepak Arumukhom Revi, MS
          • Phone Number: 614-313-3081
          • Email: dheepak1@bu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be able to communicate with investigators clearly
  • The ability to walk without another individual supporting the person's body weight for at least 6 minutes. Assistive devices, such as a cane, are allowed.

Exclusion Criteria:

  • Inability to communicate (as assessed by a licensed physical therapist)
  • Pain that impairs walking ability (as assessed by a licensed physical therapist)
  • Unexplained dizziness in the last 6 months (self-report)
  • Severe comorbidities that affect walking or may interfere with the ability to participate in the study (musculoskeletal, cardiovascular, pulmonary, and neurological)
  • More than 2 falls in the previous month

Stroke-specific Inclusion Criteria:

  • at least 6 months post-stroke

Older adults specific Inclusion Criteria:

  • 65 to 80 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Walking without personalized rhythmic auditory stimulation
Subjects will complete a 6MWT without any auditory cues
Behavioral: Active walking
walking without RAS cue
Experimental: Walking with personalized rhythmic auditory stimulation
Subjects will complete a 6MWT with personalized rhythmic auditory cues
Device: Subject-specific optimized RAS
Walking with metronome-based RAS cueing
Other Names:
  • RAS
Behavioral: Active walking
walking without RAS cue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six Minute Walk test distance
Time Frame: [RAS-Baseline]
difference in total distance walked with and without RAS within population. (m)
[RAS-Baseline]
Stride time variability
Time Frame: [RAS-Baseline]
difference in stride time variability with and without RAS (%) within population
[RAS-Baseline]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic Cost of Transport
Time Frame: [RAS-Baseline]
difference in energy cost of walking with and without RAS. Metabolic cost of transport is defined as metabolic energy (measured directly from COSMED) per kg of body weight (in mL/s/kg or W/kg) divided by the average speed during the six minute walk test within population (mL/kg/m or J/kg/m).
[RAS-Baseline]
Ground Reaction Forces
Time Frame: [RAS-Baseline]
difference in Anterior Posterior GRF within population -- including both peak and impulse (%bw)
[RAS-Baseline]
speed changes over the 6MWT
Time Frame: [RAS-Baseline]
the difference in changes in walking speed over the 6MWT within population (m/s)
[RAS-Baseline]
stride length changes over the 6MWT
Time Frame: [RAS-Baseline]
the difference in changes in stride length over the 6MWT within population(cm)
[RAS-Baseline]
cadence changes over the 6MWT
Time Frame: [RAS-Baseline]
the difference in changes in cadence over the 6MWT within population (steps/min)
[RAS-Baseline]

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke vs. older adults: Stride time Variability in responders
Time Frame: [RAS-Baseline]
difference in stride time variability with and without RAS (%) for responders across population
[RAS-Baseline]
Stroke vs. older adults: Six Minute Walk test distance in responders
Time Frame: [RAS-Baseline]
difference in total distance walked with and without RAS for responders across population
[RAS-Baseline]
spatial temporal relationships over the 6MWT: Speed to Cadence
Time Frame: [RAS-Baseline]
the difference in changes in a relationship (linear regression) between speed and cadence within population
[RAS-Baseline]
spatial temporal relationships over the 6MWT: Speed to Stride length
Time Frame: [RAS-Baseline]
the difference in changes in a relationship (linear regression) between speed and stride length within population
[RAS-Baseline]
spatial temporal relationships over the 6MWT: Cadence to Stride length
Time Frame: [RAS-Baseline]
the difference in changes in a relationship (linear regression) between cadence and stride length within population
[RAS-Baseline]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University Charles River Campus

Investigators

  • Principal Investigator: Louis Awad, PT, DPT, PhD, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4440-SK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified subject data with and without RAS may be published as part of the manuscript. Data may include, kinematics, kinetics, metabolic and clinical data.

IPD Sharing Time Frame

At the time of manuscript acceptance

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Subject-specific optimized RAS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe