Music Role in PD Rehabilitation

The Role of Music in Improving Gait Abnormalities in Parkinson Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Gait Trainer 3

Detailed 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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sicily
    • Messina, Sicily, Italy, 98123
      • IRCCS Centro Neurolesi "Bonino-Pulejo"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; The investigators will enroll 30 patients with PD, randomly divided into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The 15 patients in the experimental group will perform training by means of the device Gait Trainer 3 (Biodex), where they will train on a tredmill equipped with music. They will walk following specific musical beets and rhythms so to entrain their own internal rhythm. Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.	Device: Gait Trainer 3; 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
Active Comparator: Control Group; The control group will perform only conventional gait treadmill training, besides physical exercises to improve muscle force and tone. Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.	Device: Gait Trainer 3; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ten meters walking test	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.	about 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalogram	It can be employed to evaluate the improvement in functional connectivity, i.e. the dinamic relation between different brain areas.	about 4 weeks

Collaborators and Investigators

• Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Investigators: Study Director: Placido Bramanti, MD, IRCCS Neurolesi

Publications and helpful links

General Publications

• Calabro RS, Naro A, Filoni S, Pullia M, Billeri L, Tomasello P, Portaro S, Di Lorenzo G, Tomaino C, Bramanti P. Walking to your right music: a randomized controlled trial on the novel use of treadmill plus music in Parkinson's disease. J Neuroeng Rehabil. 2019 Jun 7;16(1):68. doi: 10.1186/s12984-019-0533-9.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): June 5, 2018

Study Registration Dates

• First Submitted: January 31, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2018
• Last Update Submitted That Met QC Criteria: July 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: PD; Gait training 3; treadmill.
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 12/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes