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Withdrawn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
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
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
NCT ID
NCT03278639
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
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
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