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

Not Applicable

Withdrawn

• Conditions: Parkinson Disease
• Interventions: Behavioral: Kinesiology; Behavioral: Rhythmic Auditory Stimulation

• Registration Number: NCT03278639
• Lead Sponsor: Pontifical Catholic University of Argentina

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 available

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Study Start: 2021-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kinesiology	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.
Rhythmic auditory stimulation	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.

Primary Outcome Measures

Name	Time	Method
change from baseline in Tinetti scale total score	4 weeks

Secondary Outcome Measures

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