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Completed

NCT Number: NCT03656796

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Zhong Cheng, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill training with auditory cues

Other

Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min

Other names: AC

Treadmill training without auditory cues

Other

Participants should walk in comfortable speed on the treadmill for 30 min.

Other names: NC

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. Stepping-in-place test

    Time frame: 5 min

    The foot sensors are used to measure the stepping variability between each step.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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