search
Back to results

Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease (ERA-EP2)

Primary Purpose

Parkinson Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhythmic Auditory Stimulation
Kinesiology
Sponsored by
Pontifical Catholic University of Argentina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinically definitive or probable PD diagnosis
  • Gait disorders (MDS-UPDRS #2.12 =1)
  • Patients that can be reasonably expected to remain in ON-state during training sessions.

Exclusion Criteria:

  • Previous use of RAS or kinesiology
  • MMSE >= 24
  • BDI >= 17
  • Patients having undergone PD surgical treatments.
  • Patients with auditory or visual handicaps

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Rhythmic auditory stimulation

    Kinesiology

    Arm Description

    Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS.

    Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS.

    Outcomes

    Primary Outcome Measures

    change from baseline in Tinetti scale total score

    Secondary Outcome Measures

    change from baseline in Tinetti scale Gait score
    change from baseline in Tinetti scale Balance score
    change from baseline in Tinetti scale total score
    training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.
    change from baseline in Timed Up & Go test (TUG)
    change from baseline in PDQ-39 scores
    PDQ-39 is a PD-specific scale for Health-related Quality of Life
    change from baseline in MDS-UPDRS score
    MDS-UPDRS is a measure of disease severity
    change from baseline in Beck Depression Index (BDI)
    change from baseline in MMSE (Mini-Mental State Examination)
    MMSE is a measure of cognitive impairment
    change from baseline in Fall diary
    patients will have to indicate the number of daily falls over a 15-d period

    Full Information

    First Posted
    September 6, 2017
    Last Updated
    September 14, 2021
    Sponsor
    Pontifical Catholic University of Argentina
    Collaborators
    National Council of Scientific and Technical Research, Argentina, Hospital Nacional Profesor Alejandro Posadas, University of Buenos Aires
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03278639
    Brief Title
    Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
    Acronym
    ERA-EP2
    Official Title
    Randomized, Blind, Controlled Clinical Trial to Assess the Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    We could not fund the study
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pontifical Catholic University of Argentina
    Collaborators
    National Council of Scientific and Technical Research, Argentina, Hospital Nacional Profesor Alejandro Posadas, University of Buenos Aires

    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
    Gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of Parkinson's disease (PD). Rhythmic Auditory Stimulation (RAS) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. In this study, auditory stimuli will be constituted by Tango musical pieces, which tempo is modified to adapt to patients' walking cadence. Previous results suggested that RAS can increase Tinetti's gait and balance and may also improve Health-Related Quality of Life. This will be a randomized, blind, controlled clinical trial to further assess RAS efficacy and safety.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized, prospective, blind, controlled clinical trial
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Both investigators taking care of patients and outcomes assessors will be blinded.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Rhythmic auditory stimulation
    Arm Type
    Experimental
    Arm Description
    Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by music therapists board-certified in RAS.
    Arm Title
    Kinesiology
    Arm Type
    Active Comparator
    Arm Description
    Each patient will receive training for 4 weeks, 3 times per week. Each training session will last 30 minutes. Training will be performed by board-certified kinesio therapists. The objectives of the training sessions will match those of RAS.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Rhythmic Auditory Stimulation
    Intervention Description
    Training will be directed to ameliorate gait and balance
    Intervention Type
    Behavioral
    Intervention Name(s)
    Kinesiology
    Intervention Description
    Training will be directed to ameliorate gait and balance
    Primary Outcome Measure Information:
    Title
    change from baseline in Tinetti scale total score
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    change from baseline in Tinetti scale Gait score
    Time Frame
    4 weeks
    Title
    change from baseline in Tinetti scale Balance score
    Time Frame
    4 weeks
    Title
    change from baseline in Tinetti scale total score
    Description
    training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.
    Time Frame
    6 months
    Title
    change from baseline in Timed Up & Go test (TUG)
    Time Frame
    4 weeks
    Title
    change from baseline in PDQ-39 scores
    Description
    PDQ-39 is a PD-specific scale for Health-related Quality of Life
    Time Frame
    4 weeks
    Title
    change from baseline in MDS-UPDRS score
    Description
    MDS-UPDRS is a measure of disease severity
    Time Frame
    4 weeks
    Title
    change from baseline in Beck Depression Index (BDI)
    Time Frame
    4 weeks
    Title
    change from baseline in MMSE (Mini-Mental State Examination)
    Description
    MMSE is a measure of cognitive impairment
    Time Frame
    4 weeks
    Title
    change from baseline in Fall diary
    Description
    patients will have to indicate the number of daily falls over a 15-d period
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    change from baseline in PD CRS
    Description
    Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance
    Time Frame
    4 weeks and 6 months
    Title
    change from baseline in DRS
    Description
    Dementia Rating Scale (DRS) measures cognitive performance
    Time Frame
    4 weeks and 6 months
    Title
    change from baseline in TUG
    Time Frame
    6 months
    Title
    change from baseline in PDQ-39
    Time Frame
    6 months
    Title
    change from baseline in MDS-UPDRS
    Time Frame
    6 months
    Title
    change from baseline in BDI
    Time Frame
    6 months
    Title
    change from baseline in MMSE
    Time Frame
    6 months
    Title
    change from baseline in fall diary
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinically definitive or probable PD diagnosis Gait disorders (MDS-UPDRS #2.12 =1) Patients that can be reasonably expected to remain in ON-state during training sessions. Exclusion Criteria: Previous use of RAS or kinesiology MMSE >= 24 BDI >= 17 Patients having undergone PD surgical treatments. Patients with auditory or visual handicaps

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease

    We'll reach out to this number within 24 hrs