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

NCT ID: NCT03656796

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2019-04-02

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD with freezing of gait (FOG)

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Group Type: EXPERIMENTAL

Treadmill training with auditory cues

Intervention Type: OTHER

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

Treadmill training without auditory cues

Intervention Type: OTHER

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

PD without freezing of gait (FOG)

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Group Type: EXPERIMENTAL

Treadmill training with auditory cues

Intervention Type: OTHER

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

Treadmill training without auditory cues

Intervention Type: OTHER

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

Healthy subjects (Control)

Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).

Group Type: EXPERIMENTAL

Treadmill training with auditory cues

Intervention Type: OTHER

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

Treadmill training without auditory cues

Intervention Type: OTHER

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

Interventions

Treadmill training with auditory cues

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

Intervention Type: OTHER

Treadmill training without auditory cues

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

Intervention Type: OTHER

Other Intervention Names

AC; NC

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jer-Junn Luh, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

National Taiwan University Hospital

Taipei, Zhong Cheng, Taiwan

Countries

Taiwan

Other Identifiers

201802068RINC

Identifier Type: -

Identifier Source: org_study_id