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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Treadmill training with auditory cues; Other: Treadmill training without auditory cues

• Registration Number: NCT03656796
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2018-04-23
• Primary Completion: 2018-07-09
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Status Verified: 2019-03
• Study Completion: 2019-04-02
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PD without freezing of gait (FOG)	Treadmill training without auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Healthy subjects (Control)	Treadmill training without auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
PD with freezing of gait (FOG)	Treadmill training without auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Healthy subjects (Control)	Treadmill training with auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
PD with freezing of gait (FOG)	Treadmill training with auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
PD without freezing of gait (FOG)	Treadmill training with auditory cues	Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Primary Outcome Measures

Name	Time	Method
Transcranial magnetic stimulation (TMS)	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 Outcome Measures

Name	Time	Method
Stepping-in-place test	5 min	The foot sensors are used to measure the stepping variability between each step.
10 meter walking test	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Zhong Cheng, Taiwan