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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Rhythmic Auditory Stimulation; Behavioral: Kinesiology

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Rhythmic Auditory Stimulation; Training will be directed to ameliorate gait and balance
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.	Behavioral: Kinesiology; Training will be directed to ameliorate gait and balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in Tinetti scale total score	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in Tinetti scale Gait score		4 weeks
change from baseline in Tinetti scale Balance score		4 weeks
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.	6 months
change from baseline in Timed Up & Go test (TUG)		4 weeks
change from baseline in PDQ-39 scores	PDQ-39 is a PD-specific scale for Health-related Quality of Life	4 weeks
change from baseline in MDS-UPDRS score	MDS-UPDRS is a measure of disease severity	4 weeks
change from baseline in Beck Depression Index (BDI)		4 weeks
change from baseline in MMSE (Mini-Mental State Examination)	MMSE is a measure of cognitive impairment	4 weeks
change from baseline in Fall diary	patients will have to indicate the number of daily falls over a 15-d period	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in PD CRS	Parkinson's Disease Cognitive Rating Scale (PD CRS) measures cognitive performance	4 weeks and 6 months
change from baseline in DRS	Dementia Rating Scale (DRS) measures cognitive performance	4 weeks and 6 months
change from baseline in TUG		6 months
change from baseline in PDQ-39		6 months
change from baseline in MDS-UPDRS		6 months
change from baseline in BDI		6 months
change from baseline in MMSE		6 months
change from baseline in fall diary		6 months

Collaborators and Investigators

• Sponsor: Pontifical Catholic University of Argentina
• Collaborators: University of Buenos Aires; National Council of Scientific and Technical Research, Argentina; Hospital Nacional Profesor Alejandro Posadas

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: music; gait disorders; balance disorders; tango; rhythmic auditory stimulation; health-related quality of life
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ERAEP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No