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

Pontifical Catholic University of Argentina

Status: Withdrawn

Conditions: Parkinson Disease

Treatments: Behavioral: Rhythmic Auditory Stimulation; Behavioral: Kinesiology

Study type: Interventional

Funder types: Other

Identifiers

NCT03278639

ERAEP2

Details and patient eligibility

About

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.

Sex: All

Ages: 60 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Rhythmic auditory stimulation

Experimental group

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.

Treatment:

Behavioral: Rhythmic Auditory Stimulation

Kinesiology

Active Comparator group

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.

Treatment:

Behavioral: Kinesiology