Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Treadmill training with auditory cues
Treadmill training without auditory cues
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring PD, Auditory cueing, TMS
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
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
PD with freezing of gait (FOG)
PD without freezing of gait (FOG)
Healthy subjects (Control)
Arm Description
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Outcomes
Primary Outcome Measures
Transcranial magnetic stimulation (TMS)
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
10 meter walking test
The foot sensors is used to measure the coefficient of variance of step time (step time CV), gait velocity, stride length, and cadence.
Stepping-in-place test
The foot sensors are used to measure the stepping variability between each step.
Full Information
NCT ID
NCT03656796
First Posted
August 30, 2018
Last Updated
September 24, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03656796
Brief Title
Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD
Official Title
Effects of Rhythmic Auditory Cueing With Locomotion Training on Cortical Excitability and Behavior in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
July 9, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
PD, Auditory cueing, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PD with freezing of gait (FOG)
Arm Type
Experimental
Arm Description
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Arm Title
PD without freezing of gait (FOG)
Arm Type
Experimental
Arm Description
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Arm Title
Healthy subjects (Control)
Arm Type
Experimental
Arm Description
Intervention will include treadmill training with auditory cues (AC) and treadmill training without auditory cues (NC).
Intervention Type
Other
Intervention Name(s)
Treadmill training with auditory cues
Other Intervention Name(s)
AC
Intervention Description
Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
Intervention Type
Other
Intervention Name(s)
Treadmill training without auditory cues
Other Intervention Name(s)
NC
Intervention Description
Participants should walk in comfortable speed on the treadmill for 30 min.
Primary Outcome Measure Information:
Title
Transcranial magnetic stimulation (TMS)
Description
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)
Time Frame
40 min
Secondary Outcome Measure Information:
Title
10 meter walking test
Description
The foot sensors is used to measure the coefficient of variance of step time (step time CV), gait velocity, stride length, and cadence.
Time Frame
10 min
Title
Stepping-in-place test
Description
The foot sensors are used to measure the stepping variability between each step.
Time Frame
5 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jer-Junn Luh, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhong Cheng
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Effects of RAC With Locomotion Training on Cortical Excitability and Behavior in Patients With PD
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