Music Role in PD Rehabilitation

Parkinson Disease Clinical Trial

Official title:

The Role of Music in Improving Gait Abnormalities in Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434496
• Other study ID #: 12/2017
• Status: Completed
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: June 5, 2018

Study information

• Verified date: February 2018
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 5, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Centro Neurolesi "Bonino-Pulejo"	Messina	Sicily

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

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