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Completed

NCT Number: NCT03434496

Music Role in PD Rehabilitation

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, Sicily, 98123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients affected by PD;
  • MMSE > 21
  • Hoehn and Yahr <3

Exclusion criteria

  • Presence of severe cognitive deficit
  • Severe motor impairment (Hoehn and Yahr >3)
  • Medical illness potentially interfering with the training

Treatment and study plan

Gait Trainer 3

Device

With the BIODEX Gait Trainer 3, patients acquire a smooth gait pattern. In addition, balance, coordination, endurance and the cardiovascular system are trained. Work on the treadmill strengthens the leg muscles. On the screen or via an audio message, the patients and therapists receive direct feedback on the smoothness of the gait pattern. The therapists can then make corrective interventions if necessary and the patients are motivated.

Other names: Conventional physioterapy

Primary outcomes

  1. Ten meters walking test

    Time frame: about 4 weeks

    It is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

Secondary outcomes

  1. Electroencephalogram

    Time frame: about 4 weeks

    It can be employed to evaluate the improvement in functional connectivity, i.e. the dinamic relation between different brain areas.

Sponsors and collaborators

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Other

Registry information

Official study title

The Role of Music in Improving Gait Abnormalities in Parkinson Disease

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 15, 2018
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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