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.
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
- What is being tested?
- Subject-specific optimized RAS and Active walking
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- 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 group | Role | What they receive |
|---|---|---|
| Walking without personalized rhythmic auditory stimulation | Active comparator | Subjects will complete a 6MWT without any auditory cues Receives: Behavioral: Active walking |
| Walking with personalized rhythmic auditory stimulation | Experimental | Subjects 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.
Six Minute Walk test distance
difference in total distance walked with and without RAS within population. (m)
Measured: [RAS-Baseline]
Stride time variability
difference in stride time variability with and without RAS (%) within population
Measured: [RAS-Baseline]
Secondary outcomes (5)
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]
Ground Reaction Forces
difference in Anterior Posterior GRF within population -- including both peak and impulse (%bw)
Measured: [RAS-Baseline]
speed changes over the 6MWT
the difference in changes in walking speed over the 6MWT within population (m/s)
Measured: [RAS-Baseline]
stride length changes over the 6MWT
the difference in changes in stride length over the 6MWT within population(cm)
Measured: [RAS-Baseline]
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.
- First posted16 Oct 2023
- Study start18 Sep 2023
- Primary completion22 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Awad, PT, DPT, PhD, Principal investigator, Boston University
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 35078371Awad 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 31449180Flansbjer 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 15788341GBD 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 34487721Reisman 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 19126838Farris 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 25889030Combs 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 23035811Bowden 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 16456121Roelker 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 30408710Kuo 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 20023002Sawicki 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 19550204Riley 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 16905322Bayat 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 15883355Puh 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 18608434Arumukhom 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responders to Metronome-based Rhythmic Auditory Stimulation in Individuals Post-Stroke and Older Adults
- ClinicalTrials.gov ID
- NCT06085248
- Acronym / sponsor ID
- 4440-SK
- Keywords
- rhythmic auditory stimulation (RAS), gait analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 22 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will complete a 6MWT without RAS and then complete a 6MWT with RAS
| Arm | Type | Receives |
|---|---|---|
| Walking without personalized rhythmic auditory stimulation | Active comparator | Behavioral: Active walkingSubjects will complete a 6MWT without any auditory cues |
| Walking with personalized rhythmic auditory stimulation | Experimental | Other: Subject-specific optimized RAS, Behavioral: Active walkingSubjects will complete a 6MWT with personalized rhythmic auditory cues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subject-specific optimized RASAlso: RASWalking with metronome-based RAS cueing | Other | Walking with personalized rhythmic auditory stimulation |
| Active walkingwalking without RAS cue | Behavioural | Walking with personalized rhythmic auditory stimulation, Walking without personalized rhythmic auditory stimulation |
Primary outcome
Six Minute Walk test distance
Time frame: [RAS-Baseline]
difference in total distance walked with and without RAS within population. (m)
Stride time variability
Time frame: [RAS-Baseline]
difference in stride time variability with and without RAS (%) within population
5 secondary outcomes
Metabolic Cost of Transport
Time frame: [RAS-Baseline]
Ground Reaction Forces
Time frame: [RAS-Baseline]
speed changes over the 6MWT
Time frame: [RAS-Baseline]
stride length changes over the 6MWT
Time frame: [RAS-Baseline]
cadence changes over the 6MWT
Time frame: [RAS-Baseline]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 35078371Tsao 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.
- Background: PubMed 31449180Awad 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.
- Background: PubMed 15788341Flansbjer 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.
- Background: PubMed 34487721GBD 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.
- Background: PubMed 19126838Reisman 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.
- Background: PubMed 25889030Farris 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.
- Background: PubMed 23035811Combs 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.
- Background: PubMed 16456121Bowden 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.
- Background: PubMed 30408710Roelker 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.
- Background: PubMed 20023002Kuo 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.
- Background: PubMed 19550204Sawicki 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.
- Background: PubMed 16905322Riley 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.
- Individual participant dataSharing planned: 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.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Awad, PT, DPT, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
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.