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Responders to Rhythmic Auditory Cueing in Parkinson Disease

Sponsor
Boston University Charles River Campus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05733819
Collaborator
Terry Ellis, PT, PhD (Other)
30
Enrollment
1
Location
2
Arms
3.8
Anticipated Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Subject-specific optimized RAS
  • Behavioral: Active Walking
 Phase 1

Detailed Description

Parkinson Disease (PD) is one of the fastest-growing sources of disability among neurological populations. PD is a progressive movement disorder characterized by substantial walking-related disability. Loss of function and quality of walking can subsequently lead to declines in walking which can precipitate a cycle of disability and deconditioning. In particular, persons with PD often demonstrate a reduction in stride length and an increase in stride time variability. These gait changes can reduce mobility and increase the risk of falls. Improving walking has been identified as the greatest priority among persons with PD for improving independence and quality of life. Therefore, interventions targeting improvements in walking function and gait quality are needed to mitigate a walking-related disability.

Rhythmic Auditory Stimulation (RAS) is a rehabilitation intervention that, unlike pharmacologic treatment, has shown promise for improving walking in PD. Walking with RAS intervention has been shown to improve walking function, particularly walking speed. RAS relies on the robust human capacity to synchronize movements to an external rhythm (i.e., walking to a regular auditory beat), a process referred to as auditory-motor entrainment. Due to the body's preference to select a walking frequency that maximizes stability and minimizes energy expenditure, rhythmic entrainment may stabilize gait patterns and reduce the metabolic cost of walking. Moreover, rhythmic entrainment is thought to reduce the attentional demand of walking in persons with PD, allowing for attention to be allocated to secondary tasks essential for safe community navigation. Despite evidence of the effectiveness of improving walking speed and gait function, the biomechanical changes that enable this improvement are not well understood.

Moreover, while RAS is an effective treatment, not everyone benefits from the treatment equally. Individuals with PD have a wide variety of gait presentations, and gait impairment may affect the efficacy of RAS treatment. In this study, the investigators want to understand who responds to RAS interventions and if the investigators can identify these responders from baseline measurements. For this analysis, the investigators define responders in three ways: (1) individuals who increase walking function, (2) individuals who increase gait quality, or (3) individuals who increase both gait quality and walking function while walking to personalized RAS. The investigators hypothesize that individuals who increase walking function and/or gait quality while walking to personalized RAS are more likely to be responsive to long-term intervention with RAS; however, the mechanism of action that enables the long-term response is hypothesized to be different based on baseline deficits. The investigators posit that the short-term responses to RAS measured in this study may suggest potential long-term mechanisms.

Study Protocol:

To examine the different effects of the intervention, each participant will complete a data collection session with a series of clinical tests including the Mini-BEST, UPDRS, the 10-m walk test (10MWT) at comfortable and fast walking speed, and the 6-minute walk test (6MWT) to quantity baseline function. Moreover, the 6MWT will be fully instrumented using motion capture cameras that track retro-reflective markers, wireless inertial measurement units, and force plates embedded in the walkway---together, these systems will enable concurrent collection of gait kinematic, inertial, and kinetic signals respectively. Additionally, metabolic measures will be collected during the 6MWT. After the baseline 6-minute walk test, participants will wear a custom, simple RAS device that will use a metronome application and bone-conducting headphones to provide auditory cues designed to modulate the participant's walking cadence. The auditory cues provided will be subject-specific based on a tuning procedure. Finally, the 6MWT will be repeated with RAS set to the optimally selected cadence based on the tuning procedure.

The primary objective of this study is to determine the effect of personalized RAS on walking function (i.e., 6MWT total distance) and gait quality (i.e., stride time variability). The investigators will also evaluate RAS-induced changes in other, secondary gait quality metrics: (1) the metabolic cost of transport, (2) walking ground reaction forces, (3) joint kinetics, and (4) distance-induced changes in spatial-temporal gait parameters. A secondary objective is to determine if RAS-induced changes in walking function and/or gait quality are related to specific patterns of baseline walking and gait impairment (i.e., movement phenotypes).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Subjects will complete a 6MWT without RAS and then complete a 6MWT with RASSubjects will complete a 6MWT without RAS and then complete a 6MWT with RAS
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Responders to Metronome-based Rhythmic Auditory Cueing in Parkinson Disease
Actual Study Start Date :
Jan 17, 2023
Anticipated Primary Completion Date :
May 12, 2023
Anticipated Study Completion Date :
May 12, 2023

Arms and Interventions

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 cueing
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 cueing

    Outcome Measures

    Primary Outcome Measures

    1. Six Minute Walk test distance [[RAS-Baseline]]

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

    2. Stride time variability [[RAS-Baseline]]

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

    Secondary Outcome Measures

    1. Metabolic Cost of Transport [[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 (mL/kg/m or J/kg/m).

    2. Ground Reaction Forces [[RAS-Baseline]]

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

    3. Joint power [[RAS-Baseline]]

      difference in joint power computed using inverse dynamics -- including ankle, knee, and hip moment. (W/kg)

    4. speed changes over the 6MWT [[RAS-Baseline]]

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

    5. stride length changes over the 6MWT [[RAS-Baseline]]

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

    6. cadence changes over the 6MWT [[RAS-Baseline]]

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

    Other Outcome Measures

    1. Joint moments [[RAS-Baseline]]

      difference in joint moments computed using inverse dynamics -- including ankle, knee, and hip moment. (Nm/kg)

    2. spatial temporal relationships over the 6MWT [[RAS-Baseline]]

      difference in changes in relationship (linear regression) between speed: cadence, speed: stride length and cadence: stride-length

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston University Neuromotor Recovery Laboratory Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Boston University Charles River Campus
    • Terry Ellis, PT, PhD

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lou Awad, PT, DPT, PhD, Assistant Professor, Boston University Charles River Campus
    ClinicalTrials.gov Identifier:
    NCT05733819
    Other Study ID Numbers:
    • 4440-PD
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 21, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lou Awad, PT, DPT, PhD, Assistant Professor, Boston University Charles River Campus
    rhythmic auditory stimulation (RAS)
    gait analysis
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Feb 21, 2023