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

Pontifical Catholic University of Argentina

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Parkinson Disease

Interventions

Rhythmic Auditory StimulationBEHAVIORAL

Training will be directed to ameliorate gait and balance

KinesiologyBEHAVIORAL

Training will be directed to ameliorate gait and balance

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

change from baseline in Tinetti scale total score

Time frame: 4 weeks

Secondary Outcomes

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

training will last for the first 4 weeks. Assessments will be also performed at Month 6 to check lasting effects.

Time frame: 6 months

change from baseline in Timed Up & Go test (TUG)

Time frame: 4 weeks

change from baseline in PDQ-39 scores

PDQ-39 is a PD-specific scale for Health-related Quality of Life

Time frame: 4 weeks

change from baseline in MDS-UPDRS score

MDS-UPDRS is a measure of disease severity

Time frame: 4 weeks

change from baseline in Beck Depression Index (BDI)

Time frame: 4 weeks

change from baseline in MMSE (Mini-Mental State Examination)

MMSE is a measure of cognitive impairment

Time frame: 4 weeks

change from baseline in Fall diary

patients will have to indicate the number of daily falls over a 15-d period

Data from ClinicalTrials.gov

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