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StrokeNCT06085248

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

A study testing Subject-specific optimized RAS and Active walking in people with Stroke and Old Age, run by Boston University Charles River Campus at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Old Age
What is being tested?
Subject-specific optimized RAS and Active walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
18 Sep 2023to 1 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 9Show fewer
  • at least 6 months post-stroke
  • Older adults specific Inclusion Criteria:
  • 65 to 80 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston University Neuromotor Recovery Laboratory

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Stroke, Old Age
Being tested
Subject-specific optimized RAS, Active walking
Keywords
rhythmic auditory stimulation (RAS), gait analysis
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subject-specific optimized RASOther

    Also called RAS

    Walking with metronome-based RAS cueing

  • Active walkingBehavioural

    walking without RAS cue

Study groups in NCT06085248
Study groupRoleWhat they receive
Walking without personalized rhythmic auditory stimulationActive comparatorSubjects will complete a 6MWT without any auditory cues
Receives: Behavioral: Active walking
Walking with personalized rhythmic auditory stimulationExperimentalSubjects will complete a 6MWT with personalized rhythmic auditory cues
Receives: Other: Subject-specific optimized RAS; Behavioral: Active walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Six Minute Walk test distance

    difference in total distance walked with and without RAS within population. (m)

    Measured: [RAS-Baseline]

  2. Stride time variability

    difference in stride time variability with and without RAS (%) within population

    Measured: [RAS-Baseline]

Secondary outcomes (5)
  1. Metabolic Cost of Transport

    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).

    Measured: [RAS-Baseline]

  2. Ground Reaction Forces

    difference in Anterior Posterior GRF within population -- including both peak and impulse (%bw)

    Measured: [RAS-Baseline]

  3. speed changes over the 6MWT

    the difference in changes in walking speed over the 6MWT within population (m/s)

    Measured: [RAS-Baseline]

  4. stride length changes over the 6MWT

    the difference in changes in stride length over the 6MWT within population(cm)

    Measured: [RAS-Baseline]

  5. cadence changes over the 6MWT

    the difference in changes in cadence over the 6MWT within population (steps/min)

    Measured: [RAS-Baseline]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2023
  2. Study start18 Sep 2023
  3. Primary completion22 Mar 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Crossover
Model description
Subjects will complete a 6MWT without RAS and then complete a 6MWT with RAS
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06085248
Sponsor's protocol ID
4440-SK
Status last verified
Aug 2026
First submitted
9 Oct 2023
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified subject data with and without RAS may be published as part of the manuscript. Data may include, kinematics, kinetics, metabolic and clinical data.

Publications

  • Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.

    PubMed 35078371
  • Awad L, Reisman D, Binder-Macleod S. Distance-Induced Changes in Walking Speed After Stroke: Relationship to Community Walking Activity. J Neurol Phys Ther. 2019 Oct;43(4):220-223. doi: 10.1097/NPT.0000000000000293.

    PubMed 31449180
  • Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.

    PubMed 15788341
  • GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

    PubMed 34487721
  • Reisman DS, Rudolph KS, Farquhar WB. Influence of speed on walking economy poststroke. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):529-34. doi: 10.1177/1545968308328732. Epub 2009 Jan 6.

    PubMed 19126838
  • Farris DJ, Hampton A, Lewek MD, Sawicki GS. Revisiting the mechanics and energetics of walking in individuals with chronic hemiparesis following stroke: from individual limbs to lower limb joints. J Neuroeng Rehabil. 2015 Feb 27;12:24. doi: 10.1186/s12984-015-0012-x.

    PubMed 25889030
  • Combs SA, Van Puymbroeck M, Altenburger PA, Miller KK, Dierks TA, Schmid AA. Is walking faster or walking farther more important to persons with chronic stroke? Disabil Rehabil. 2013 May;35(10):860-7. doi: 10.3109/09638288.2012.717575. Epub 2012 Oct 5.

    PubMed 23035811
  • Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.

    PubMed 16456121
  • Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.

    PubMed 30408710
  • Kuo AD, Donelan JM. Dynamic principles of gait and their clinical implications. Phys Ther. 2010 Feb;90(2):157-74. doi: 10.2522/ptj.20090125. Epub 2009 Dec 18.

    PubMed 20023002
  • Sawicki GS, Lewis CL, Ferris DP. It pays to have a spring in your step. Exerc Sport Sci Rev. 2009 Jul;37(3):130-8. doi: 10.1097/JES.0b013e31819c2df6.

    PubMed 19550204
  • Riley PO, Paolini G, Della Croce U, Paylo KW, Kerrigan DC. A kinematic and kinetic comparison of overground and treadmill walking in healthy subjects. Gait Posture. 2007 Jun;26(1):17-24. doi: 10.1016/j.gaitpost.2006.07.003. Epub 2006 Aug 14.

    PubMed 16905322
  • Bayat R, Barbeau H, Lamontagne A. Speed and temporal-distance adaptations during treadmill and overground walking following stroke. Neurorehabil Neural Repair. 2005 Jun;19(2):115-24. doi: 10.1177/1545968305275286.

    PubMed 15883355
  • Puh U, Baer GD. A comparison of treadmill walking and overground walking in independently ambulant stroke patients: a pilot study. Disabil Rehabil. 2009;31(3):202-10. doi: 10.1080/09638280801903039.

    PubMed 18608434
  • Arumukhom Revi, D., et.al. Propulsion Asymmetry Is Associated with an Inefficient Compensatory Ankle-to-Hip Redistribution of Positive Power after Stroke. Combined Sections Meeting 2023 (CSM), APTA

Questions about this trial

What is this clinical trial studying?

A study testing Subject-specific optimized RAS and Active walking in people with Stroke and Old Age, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Minute Walk test distance (time frame: [RAS-Baseline]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06085248, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.

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