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

NCT06085248 | Unknown Phase 1

• 1 other identifier: 4440-SK
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Old Age

Keywords

rhythmic auditory stimulation (RAS); gait analysis

Outcome Measures

Primary Outcomes (2)

• Six Minute Walk test distance

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

  [RAS-Baseline]

• Stride time variability

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

  [RAS-Baseline]

Secondary Outcomes (5)

• Metabolic Cost of Transport

  [RAS-Baseline]

• Ground Reaction Forces

  [RAS-Baseline]

• speed changes over the 6MWT

  [RAS-Baseline]

• stride length changes over the 6MWT

  [RAS-Baseline]

• cadence changes over the 6MWT

  [RAS-Baseline]

Other Outcomes (5)

• Stroke vs. older adults: Stride time Variability in responders

  [RAS-Baseline]

• Stroke vs. older adults: Six Minute Walk test distance in responders

  [RAS-Baseline]

• spatial temporal relationships over the 6MWT: Speed to Cadence

  [RAS-Baseline]

Study Arms (2)

Walking without personalized rhythmic auditory stimulation

ACTIVE COMPARATOR

Subjects will complete a 6MWT without any auditory cues

Behavioral: Active walking

Walking with personalized rhythmic auditory stimulation

EXPERIMENTAL

Subjects will complete a 6MWT with personalized rhythmic auditory cues

Device: Subject-specific optimized RAS; Behavioral: Active walking

Interventions

Subject-specific optimized RAS DEVICE

Walking with metronome-based RAS cueing

Also known as: RAS

Walking with personalized rhythmic auditory stimulation

Active walking BEHAVIORAL

walking without RAS cue

Walking with personalized rhythmic auditory stimulation; Walking without personalized rhythmic auditory stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• at least 6 months post-stroke
• to 80 years of age

Sponsors & Collaborators

• Boston University Charles River Campus: lead

Study Sites (1)

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

RECRUITING

Related Publications (18)

• 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.

  PMID: 35078371 BACKGROUND

• 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.

  PMID: 31449180 BACKGROUND

• 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.

  PMID: 15788341 BACKGROUND

• 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.

  PMID: 34487721 BACKGROUND

• 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.

  PMID: 19126838 BACKGROUND

• 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.

  PMID: 25889030 BACKGROUND

• 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.

  PMID: 23035811 BACKGROUND

• 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.

  PMID: 16456121 BACKGROUND

• 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.

  PMID: 30408710 BACKGROUND

• 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.

  PMID: 20023002 BACKGROUND

• 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.

  PMID: 19550204 BACKGROUND

• 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.

  PMID: 16905322 BACKGROUND

• 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.

  PMID: 15883355 BACKGROUND

• 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.

  PMID: 18608434 BACKGROUND

• 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

  BACKGROUND

• Arumukhom Revi D, De Rossi SMM, Walsh CJ, Awad LN. Estimation of Walking Speed and Its Spatiotemporal Determinants Using a Single Inertial Sensor Worn on the Thigh: From Healthy to Hemiparetic Walking. Sensors (Basel). 2021 Oct 21;21(21):6976. doi: 10.3390/s21216976.

  PMID: 34770283 BACKGROUND

• Revi DA, Alvarez AM, Walsh CJ, De Rossi SMM, Awad LN. Indirect measurement of anterior-posterior ground reaction forces using a minimal set of wearable inertial sensors: from healthy to hemiparetic walking. J Neuroeng Rehabil. 2020 Jun 29;17(1):82. doi: 10.1186/s12984-020-00700-7.

  PMID: 32600348 BACKGROUND

• Roerdink M, Bank PJ, Peper CL, Beek PJ. Walking to the beat of different drums: practical implications for the use of acoustic rhythms in gait rehabilitation. Gait Posture. 2011 Apr;33(4):690-4. doi: 10.1016/j.gaitpost.2011.03.001. Epub 2011 Mar 31.

  PMID: 21454077 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Louis Awad, PT, DPT, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dheepak Arumukhom Revi, MS

CONTACT

6143133081; dheepak1@bu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Subjects will complete a 6MWT without RAS and then complete a 6MWT with RAS

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: September 18, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the time of manuscript acceptance

Locations

US (1)