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

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ClinicalTrials.gov Identifier: NCT03278639
Recruitment Status : Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 15, 2020
Sponsor:
Collaborators:
National Council of Scientific and Technical Research, Argentina
Hospital Nacional Profesor Alejandro Posadas
University of Buenos Aires
Information provided by (Responsible Party):
Santiago Perez Lloret, Pontifical Catholic University of Argentina

Tracking Information
First Submitted Date  ICMJE September 6, 2017
First Posted Date  ICMJE September 11, 2017
Last Update Posted Date September 15, 2020
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
change from baseline in Tinetti scale total score [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
  • change from baseline in Tinetti scale Gait score [ Time Frame: 4 weeks ]
  • change from baseline in Tinetti scale Balance score [ Time Frame: 4 weeks ]
  • change from baseline in Tinetti scale total score [ Time Frame: 6 months ]
    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) [ Time Frame: 4 weeks ]
  • change from baseline in PDQ-39 scores [ Time Frame: 4 weeks ]
    PDQ-39 is a PD-specific scale for Health-related Quality of Life
  • change from baseline in MDS-UPDRS score [ Time Frame: 4 weeks ]
    MDS-UPDRS is a measure of disease severity
  • change from baseline in Beck Depression Index (BDI) [ Time Frame: 4 weeks ]
  • change from baseline in MMSE (Mini-Mental State Examination) [ Time Frame: 4 weeks ]
    MMSE is a measure of cognitive impairment
  • change from baseline in Fall diary [ Time Frame: 4 weeks ]
    patients will have to indicate the number of daily falls over a 15-d period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2017)
  • change from baseline in PD CRS [ Time Frame: 4 weeks and 6 months ]
    Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance
  • change from baseline in DRS [ Time Frame: 4 weeks and 6 months ]
    Dementia Rating Scale (DRS) measures cognitive performance
  • change from baseline in TUG [ Time Frame: 6 months ]
  • change from baseline in PDQ-39 [ Time Frame: 6 months ]
  • change from baseline in MDS-UPDRS [ Time Frame: 6 months ]
  • change from baseline in BDI [ Time Frame: 6 months ]
  • change from baseline in MMSE [ Time Frame: 6 months ]
  • change from baseline in fall diary [ Time Frame: 6 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety or Rhythmic Auditory Stimulation (RAS) for Gait and Balance Disorders in Parkinson's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized, prospective, blind, controlled clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Both investigators taking care of patients and outcomes assessors will be blinded.
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Behavioral: Rhythmic Auditory Stimulation
    Training will be directed to ameliorate gait and balance
  • Behavioral: Kinesiology
    Training will be directed to ameliorate gait and balance
Study Arms  ICMJE
  • Experimental: Rhythmic auditory stimulation
    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.
    Intervention: Behavioral: Rhythmic Auditory Stimulation
  • Active Comparator: Kinesiology
    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: Behavioral: Kinesiology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2017)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Santiago Perez-Lloret, MD PhD 005491141834429 santiagopl@conicet.gov.ar
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT03278639
Other Study ID Numbers  ICMJE ERAEP2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Santiago Perez Lloret, Pontifical Catholic University of Argentina
Study Sponsor  ICMJE Pontifical Catholic University of Argentina
Collaborators  ICMJE
  • National Council of Scientific and Technical Research, Argentina
  • Hospital Nacional Profesor Alejandro Posadas
  • University of Buenos Aires
Investigators  ICMJE Not Provided
PRS Account Pontifical Catholic University of Argentina
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP