Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD

September 24, 2019 updated by: National Taiwan University Hospital

Effects of Rhythmic Auditory Cueing With Locomotion Training on Cortical Excitability and Behavior in Patients With Parkinson's Disease

In this study, 51 subjects include 17 freezers,17 non-freezers and 17 aged-matched healthy subjects will be recruited. We will compare the cortical excitability, gait performance, and stepping-in-place performance before and after intervention of auditory cues combined with gait training. The cortical excitability will be assessed by transcranial magnetic stimulation (TMS). The purpose in this study is to investigate the effects of auditory cues with gait training on cortical excitability and rhythmic movements in patients with Parkinson's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Parkinson's disease is a common neurodegenerative disease and movement disorder. Due to the degeneration of basal ganglia, patients with Parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. To improve the rhythmic movement problems, auditory cues are often used in clinical setting and have been revealed providing benefits in ambulation and freezing problems for PD subjects. Besides, treadmill training is another common intervention to improve gait performance for PD. However, lack studies investigate the effects of auditory cues with locomotion training on brain neurophysiology and scarcer studies investigate the different effects of auditory cues between the freezers and non-freezers.

Objective: To investigate the effects of auditory-cued training on cortical excitability and motor performances in patients with PD. To investigate whether different effects of auditory cues on cortical excitability and motor performance between the freezers and non-freezers.

Methods: We will recruit 17 freezers, 17 non-freezers and 17 healthy elderly. Each participants will receive the trainings under two conditions in random order. There is one week wash-out period between two-trainings. Two-training are (1) treadmill training with concurrent auditory cues: participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min. (2) treadmill training without any auditory cues: participants should walk in comfortable speed on the treadmill for 30 min. Assessments consist of cortical excitability through transcranial magnetic stimulation (TMS), stepping-in-place test, and walking test, and they will be done before and after training.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhong Cheng
      • Taipei, Zhong Cheng, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged above 20 y/o
  • Diagnosed with idiopathic Parkinson's disease
  • No hearing impairment
  • Able to walk independently without aid
  • MMSE above 24

Exclusion Criteria:

  • Other neurological disease
  • Orthopedic problems affect gait performance
  • Psychological disorder
  • Unstable cardiovescular and respiratory status
  • Dementia
  • Visual disturbance affects gait performance
  • Contraindication of transcranial magnetic stimulation: family history of epilepsy; head injury; head surgery or metal implant; pacemaker; syncope or migraine with unknown reasons; pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD with freezing of gait (FOG)
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Other: Treadmill training with auditory cues
Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
Other Names:
  • AC
Other: Treadmill training without auditory cues
Participants should walk in comfortable speed on the treadmill for 30 min.
Other Names:
  • NC
Experimental: PD without freezing of gait (FOG)
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Other: Treadmill training with auditory cues
Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
Other Names:
  • AC
Other: Treadmill training without auditory cues
Participants should walk in comfortable speed on the treadmill for 30 min.
Other Names:
  • NC
Experimental: Healthy subjects (Control)
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Other: Treadmill training with auditory cues
Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
Other Names:
  • AC
Other: Treadmill training without auditory cues
Participants should walk in comfortable speed on the treadmill for 30 min.
Other Names:
  • NC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcranial magnetic stimulation (TMS)
Time Frame: 40 min
TMS will be used to evaluate the cortical excitability. TMS parameters include resting motor threshold (RMT), motor evoke potential (MEPs), cortical silent period (CSP), short intracortical inhibition (SICI) and intracortical facilitation (ICF)
40 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10 meter walking test
Time Frame: 10 min
The foot sensors is used to measure the coefficient of variance of step time (step time CV), gait velocity, stride length, and cadence.
10 min
Stepping-in-place test
Time Frame: 5 min
The foot sensors are used to measure the stepping variability between each step.
5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Jer-Junn Luh, PhD, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2018

Primary Completion (Actual)

July 9, 2018

Study Completion (Actual)

April 2, 2019

Study Registration Dates

First Submitted

August 30, 2018

First Submitted That Met QC Criteria

August 31, 2018

First Posted (Actual)

September 4, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201802068RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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