NCT03434496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2018

Completed
Last Updated

July 3, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

January 31, 2018

Last Update Submit

July 2, 2018

Conditions

Parkinson Disease

Keywords

PD; Gait training 3; treadmill.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Electroencephalogram

    about 4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Gait Trainer 3DEVICE

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.

Also known as: Conventional physioterapy
Control GroupExperimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro Neurolesi "Bonino-Pulejo"

Messina, Sicily, 98123, Italy

Location

Related Publications (1)

  • 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.

    PMID: 31174570DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Placido Bramanti, MD

    IRCCS Neurolesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 15, 2018

Study Start

January 3, 2018

Primary Completion

March 30, 2018

Study Completion

June 5, 2018

Last Updated

July 3, 2018

Record last verified: 2018-02

Locations

IT(1)