Responders to Rhythmic Auditory Cueing in Parkinson Disease

NCT05733819 | Completed Phase 1

• 1 other identifier: 4440-PD
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson disease (PD) is the second most common neurodegenerative disease affecting approximately 10 million people worldwide. It is a complex movement disorder that results in reduced walking ability. Prior studies have identified declines in walking as a marker of ensuing disability. Rhythmic auditory stimulation (RAS) is a rehabilitation approach that employs the coupling of auditory cues with movement. Walking with RAS has been shown to benefit walking rhythmicity, quality, and speed. These walking benefits make RAS advantageous in promoting regular moderate-intensity walking activity -- an important health objective in the management of PD. However, there is limited research investigating the effects of RAS on walking quality and how improvements in walking speed are achieved. This study will enroll 30 individuals with mild to moderate PD where each participant will be asked to complete two six-minute walk tests, one standard test (baseline) and the other using an optimized metronome-based auditory cueing RAS intervention. The investigators hypothesize that individuals with PD will either walk farther or with more automaticity (i.e., reduced stride time variability) in the RAS condition compared to the baseline condition. Moreover, these walking improvements will be accompanied by improvements in gait mechanics and metabolic cost of walking.

Conditions

Parkinson Disease

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. (m)

  [RAS-Baseline]

• Stride time variability

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

  [RAS-Baseline]

Secondary Outcomes (6)

• Metabolic Cost of Transport

  [RAS-Baseline]

• Ground Reaction Forces

  [RAS-Baseline]

• Joint power

  [RAS-Baseline]

• speed changes over the 6MWT

  [RAS-Baseline]

• stride length changes over the 6MWT

  [RAS-Baseline]

Other Outcomes (2)

• Joint moments

  [RAS-Baseline]

• spatial temporal relationships over the 6MWT

  [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 cueing

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
• Diagnosis of Parkinson's disease (self-report)
• The ability to walk continuously 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)
• Parkinson's disease, score \< 23 on the MMSE.
• Pain that impairs walking ability (as assessed by a licensed physical therapist)
• Unexplained dizziness in the last 6 months (self-report)
• Severe comorbidities that may interfere with the ability to participate (musculoskeletal, cardiovascular, pulmonary, and neurological)
• More than 2 falls in the previous month

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• Terry Ellis, PT, PhD: collaborator

Study Sites (1)

Boston University Neuromotor Recovery Laboratory

Boston, Massachusetts, 02215, United States

Location

Related Publications (13)

• Shulman LM, Gruber-Baldini AL, Anderson KE, Vaughan CG, Reich SG, Fishman PS, Weiner WJ. The evolution of disability in Parkinson disease. Mov Disord. 2008 Apr 30;23(6):790-6. doi: 10.1002/mds.21879.

  PMID: 18361474 BACKGROUND

• Shulman LM. Understanding disability in Parkinson's disease. Mov Disord. 2010;25 Suppl 1:S131-5. doi: 10.1002/mds.22789.

  PMID: 20187231 BACKGROUND

• Lord S, Godfrey A, Galna B, Mhiripiri D, Burn D, Rochester L. Ambulatory activity in incident Parkinson's: more than meets the eye? J Neurol. 2013 Dec;260(12):2964-72. doi: 10.1007/s00415-013-7037-5. Epub 2013 Jul 31.

  PMID: 23900754 BACKGROUND

• Cavanaugh JT, Ellis TD, Earhart GM, Ford MP, Foreman KB, Dibble LE. Capturing ambulatory activity decline in Parkinson's disease. J Neurol Phys Ther. 2012 Jun;36(2):51-7. doi: 10.1097/NPT.0b013e318254ba7a.

  PMID: 22592060 BACKGROUND

• Cochen De Cock V, Dotov D, Damm L, Lacombe S, Ihalainen P, Picot MC, Galtier F, Lebrun C, Giordano A, Driss V, Geny C, Garzo A, Hernandez E, Van Dyck E, Leman M, Villing R, Bardy BG, Dalla Bella S. BeatWalk: Personalized Music-Based Gait Rehabilitation in Parkinson's Disease. Front Psychol. 2021 Apr 26;12:655121. doi: 10.3389/fpsyg.2021.655121. eCollection 2021.

  PMID: 33981279 BACKGROUND

• Forte R, Tocci N, De Vito G. The Impact of Exercise Intervention with Rhythmic Auditory Stimulation to Improve Gait and Mobility in Parkinson Disease: An Umbrella Review. Brain Sci. 2021 May 22;11(6):685. doi: 10.3390/brainsci11060685.

  PMID: 34067458 BACKGROUND

• Nonnekes J, Nieuwboer A. Towards Personalized Rehabilitation for Gait Impairments in Parkinson's Disease. J Parkinsons Dis. 2018;8(s1):S101-S106. doi: 10.3233/JPD-181464.

  PMID: 30584154 BACKGROUND

• Port RJ, Rumsby M, Brown G, Harrison IF, Amjad A, Bale CJ. People with Parkinson's Disease: What Symptoms Do They Most Want to Improve and How Does This Change with Disease Duration? J Parkinsons Dis. 2021;11(2):715-724. doi: 10.3233/JPD-202346.

  PMID: 33459664 BACKGROUND

• Burrai F, Apuzzo L, Zanotti R. Effectiveness of Rhythmic Auditory Stimulation on Gait in Parkinson Disease: A Systematic Review and Meta-analysis. Holist Nurs Pract. 2024 Mar-Apr 01;38(2):109-119. doi: 10.1097/HNP.0000000000000462. Epub 2021 Jun 11.

  PMID: 34121062 BACKGROUND

• Ye X, Li L, He R, Jia Y, Poon W. Rhythmic auditory stimulation promotes gait recovery in Parkinson's patients: A systematic review and meta-analysis. Front Neurol. 2022 Jul 28;13:940419. doi: 10.3389/fneur.2022.940419. eCollection 2022.

  PMID: 35968291 BACKGROUND

• Erra C, Mileti I, Germanotta M, Petracca M, Imbimbo I, De Biase A, Rossi S, Ricciardi D, Pacilli A, Di Sipio E, Palermo E, Bentivoglio AR, Padua L. Immediate effects of rhythmic auditory stimulation on gait kinematics in Parkinson's disease ON/OFF medication. Clin Neurophysiol. 2019 Oct;130(10):1789-1797. doi: 10.1016/j.clinph.2019.07.013. Epub 2019 Jul 25.

  PMID: 31401487 BACKGROUND

• Nombela C, Hughes LE, Owen AM, Grahn JA. Into the groove: can rhythm influence Parkinson's disease? Neurosci Biobehav Rev. 2013 Dec;37(10 Pt 2):2564-70. doi: 10.1016/j.neubiorev.2013.08.003. Epub 2013 Sep 3.

  PMID: 24012774 BACKGROUND

• Ashoori A, Eagleman DM, Jankovic J. Effects of Auditory Rhythm and Music on Gait Disturbances in Parkinson's Disease. Front Neurol. 2015 Nov 11;6:234. doi: 10.3389/fneur.2015.00234. eCollection 2015.

  PMID: 26617566 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

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

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

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 17, 2023
• Study Start: January 17, 2023
• Primary Completion: June 20, 2023
• Study Completion: June 30, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

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

Locations

US (1)