Music Role in PD Rehabilitation

Status Completed

Clinical Trial Summary

Neurologic Music Therapy (NMT) sensorimotor techniques are increasingly used to improve spatio-temporal gait parameters and postural stability in the course of Parkinson's Disease and following stroke. Nonetheless, the neurophysiological underpinnings of NMT-mediated gait recovery is still poorly understood.

The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training.

Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.

Clinical Trial Description

The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training.

Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.

The investigators will assess the gait performance and pattern by using System BTS Smart for gait and the sensorimotor functional connectivity by using EEG, both before and after the therapy cycle. The patients will be clinically evaluated by means of Time up and go test, and ten meters. The overall motor function will be evaluated through the UPDRS III.

Power calculation by Cohen (1992) methodology will be utilized for this pilot study. Shapiro-Wilk test was applied to assess the normality of distribution. Thus, parametric and non-parametric tests will be employed for all comparisons (Wilcoxon test, ANOVA). Mann-Whitney test or ANOVA will be utilized to evaluate the level of significance in differentiation between the examined groups. ;

Study Design

Related Conditions & MeSH terms

Parkinson Disease

Clinical Trial Details

NCT number	NCT03434496
Study type	Interventional
Source	IRCCS Centro Neurolesi "Bonino-Pulejo"
Contact
Status	Completed
Phase	N/A
Start date	January 3, 2018
Completion date	June 5, 2018

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.