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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Rhythmic Auditory Stimulation
* Behavioral: Kinesiology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, prospective, blind, controlled clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rhythmic auditory stimulation<br>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<br>* Training will be directed to ameliorate gait and balance<br>|
| Active Comparator: Kinesiology<br>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<br>* Training will be directed to ameliorate gait and balance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait disorders, balance disorders, music, tango, rhythmic auditory stimulation, health-related quality of life