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Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease

Primary Purpose

Continuous Rhythmic Auditory Stimulation, Intermittent Rhythmic Auditory Stimulation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation (RAS)
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Continuous Rhythmic Auditory Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Hoehn & Yahr (HY) stage III or IV
  • At least 2 falls in the past 12 months
  • Stable antiparkinsonian medication regime
  • Ability to ambulate independently for at least 50 m.

Exclusion Criteria:

  • Other neurological or orthopedic conditions
  • Medically diagnosed hearing loss
  • Dementia (Mini Mental Status Exam score < 24).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Continuous RAS

    Intermittent RAS

    Arm Description

    The experimental group (continuous treatment) trained daily with RAS for 24 weeks.

    The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.

    Outcomes

    Primary Outcome Measures

    Fall Index
    The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.

    Secondary Outcome Measures

    Falls Efficacy Scale (FES)
    Falls Efficacy Scale (FES) (Tinetti et al 1990) is a 10-item scale to assess fear of falling in older persons. Individuals are asked to rate, on a 10-point scale with zero corresponding to not at all and 10 to completely, how confident he or she felt in performing 10 activities. The scores are added up to calculate a total score that ranges from 0 to 100. Higher scores indicate more confidence/less fear.
    Berg Balance Scale (BBS)
    It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function, and the final measure is the sum of all of the scores.
    Timed Up and Go (TUG)
    Measure of function (rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) with correlates to balance and fall risk. A faster time indicates a better functional performance.
    Gait
    Assessment of gait parameters (velocity, stride length, cadence, ankle dorsiflexion) with a computerized stride analyzer system (B&L Engineering).

    Full Information

    First Posted
    October 16, 2017
    Last Updated
    June 19, 2018
    Sponsor
    University of Toronto
    Collaborators
    Poudre Valley Health System Fort Collins CO, Colorado State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03316365
    Brief Title
    Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
    Official Title
    Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2009 (Actual)
    Primary Completion Date
    August 2011 (Actual)
    Study Completion Date
    August 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Toronto
    Collaborators
    Poudre Valley Health System Fort Collins CO, Colorado State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Falls are common among patients with Parkinson's Disease (PD) and are the biggest contributors to loss of independent living, long-term institutionalization, and increased mortality. The purpose of this study was to explore whether an at-home based Rhythmic Auditory Stimulation (RAS) gait training program will decrease the number of falls in persons with PD with a history of falling. We also evaluated changes in clinical and kinematic parameters used to assess fall risk in this population. Sixty participants diagnosed with idiopathic PD with at least 2 falls in the past 12 months, were randomly allocated into two groups. The experimental group trained daily with RAS for 24 weeks. The control group also trained daily with RAS, but discontinued training between weeks 8 and 16. During treatment patients walked for 30 minutes in a home based environment with metronome-click embedded music. Changes in clinical and kinematic parameters were assessed at baseline, weeks 8, 16, and 24.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Continuous Rhythmic Auditory Stimulation, Intermittent Rhythmic Auditory Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care ProviderOutcomes Assessor
    Masking Description
    Home training instructions were provided by a certified physical therapist and board-certified neurologic music therapist blinded to treatment allocation of the subjects. The TUG and the BBS were administered by an experienced physical therapist blinded to the study design.
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous RAS
    Arm Type
    Experimental
    Arm Description
    The experimental group (continuous treatment) trained daily with RAS for 24 weeks.
    Arm Title
    Intermittent RAS
    Arm Type
    Active Comparator
    Arm Description
    The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Rhythmic Auditory Stimulation (RAS)
    Other Intervention Name(s)
    Neurologic Music Therapy
    Intervention Description
    The experimental group (continuous treatment) trained daily with Rhythmic Auditory Stimulation (RAS) for 24 weeks. The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. During treatment subjects walked for 30 minutes in a home-based environment with metronome-click embedded music downloaded to an MP3 player and listened to either free-field or via headphones. For the first 8 weeks subjects had 3 metronome rates available to choose from: 100, 105, and 110% of internal usual cadence. During the second 8 weeks available rates were 105, 110 and 115%; and during the last 8 weeks 110, 115, 120%. The control group started their last training segment at 105, 110, and 115%, but could request a change to the faster rates if comfortable.
    Primary Outcome Measure Information:
    Title
    Fall Index
    Description
    The Fall Index was computed based on self-reports by subjects or caregivers and classified as 1 (incomplete fall, lost balance but stabilized by another person or object), 2 (complete fall, no injuries) or 3 (complete fall, injury, medical attention required). A complete fall was defined as unintentionally coming to the ground with any body part above ankle. Higher Fall Index values indicate higher incidence of falls.
    Time Frame
    Change of the number of fall incidents and severity from baseline assessed by the Fall Index 8 weeks, 16 weeks, and 24 weeks.
    Secondary Outcome Measure Information:
    Title
    Falls Efficacy Scale (FES)
    Description
    Falls Efficacy Scale (FES) (Tinetti et al 1990) is a 10-item scale to assess fear of falling in older persons. Individuals are asked to rate, on a 10-point scale with zero corresponding to not at all and 10 to completely, how confident he or she felt in performing 10 activities. The scores are added up to calculate a total score that ranges from 0 to 100. Higher scores indicate more confidence/less fear.
    Time Frame
    Change in level of concern about falling from baseline assessed by Fear of the Falling Questionnaire/Short FES-1 at 8 weeks, 16 weeks, and 24 weeks.
    Title
    Berg Balance Scale (BBS)
    Description
    It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function, and the final measure is the sum of all of the scores.
    Time Frame
    Change in balance from baseline assessed by Berg Balance Scale at 8 weeks, 16 weeks, and 24 weeks.
    Title
    Timed Up and Go (TUG)
    Description
    Measure of function (rise from a chair, walk three meters, turn around, walk back to the chair, and sit down) with correlates to balance and fall risk. A faster time indicates a better functional performance.
    Time Frame
    Change in balance and function from baseline assessed by Timed Up and Go at 8 weeks, 16 weeks, and 24 weeks.
    Title
    Gait
    Description
    Assessment of gait parameters (velocity, stride length, cadence, ankle dorsiflexion) with a computerized stride analyzer system (B&L Engineering).
    Time Frame
    Change in gait from baseline at 8 weeks, 16 weeks, and 24 weeks.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Hoehn & Yahr (HY) stage III or IV At least 2 falls in the past 12 months Stable antiparkinsonian medication regime Ability to ambulate independently for at least 50 m. Exclusion Criteria: Other neurological or orthopedic conditions Medically diagnosed hearing loss Dementia (Mini Mental Status Exam score < 24).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Thaut, PhD
    Organizational Affiliation
    University of Toronto
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be made available to external researchers.

    Learn more about this trial

    Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's Disease

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