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Music Role in PD Rehabilitation

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Gait Trainer 3
Sponsored by
IRCCS Centro Neurolesi "Bonino-Pulejo"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring PD; Gait training 3; treadmill.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • IRCCS Centro Neurolesi "Bonino-Pulejo"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 31, 2018
Last Updated
July 2, 2018
Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"
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1. Study Identification

Unique Protocol Identification Number
NCT03434496
Brief Title
Music Role in PD Rehabilitation
Official Title
The Role of Music in Improving Gait Abnormalities in Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Centro Neurolesi "Bonino-Pulejo"

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
PD; Gait training 3; treadmill.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Gait Trainer 3
Other Intervention Name(s)
Conventional physioterapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ten meters walking test
Description
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.
Time Frame
about 4 weeks
Secondary Outcome Measure Information:
Title
Electroencephalogram
Description
It can be employed to evaluate the improvement in functional connectivity, i.e. the dinamic relation between different brain areas.
Time Frame
about 4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Placido Bramanti, MD
Organizational Affiliation
IRCCS Neurolesi
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Centro Neurolesi "Bonino-Pulejo"
City
Messina
State/Province
Sicily
ZIP/Postal Code
98123
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31174570
Citation
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.
Results Reference
derived

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Music Role in PD Rehabilitation

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