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Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Stepping-in-place exercise with external auditory cues
Transcranial magnetic stimulation (TMS)
Sponsored by
HsiuYun Chang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Auditory cues, step in place, transcranial magnetic stimulation, cortical excitability

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

[Patients with Parkinson's disease]

Inclusion Criteria:

  • Diagnosed with idiopathic Parkinson's disease
  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE >=24)

[Healthy subjects]

  • No hearing impairment
  • Able to walk independently for at least 10m
  • Able to follow command (MMSE >=24)

Exclusion Criteria:

  • With other neurological diseases or psychological diseases
  • Dementia
  • Family history of epilepsy
  • History of head trauma, surgery, or metal implants
  • Having pacemaker or other electrical stimulators
  • History of syncopes or frequent migraines

Sites / Locations

  • Department of physical therapy, National Taiwan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Freezer

Non-freezer

Arm Description

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.

Outcomes

Primary Outcome Measures

Changes of transcranial magnetic stimulation (TMS) parameters
Single-pulse and paired-pulse TMS are used to measure the cortical excitability of the motor cortex and the integrity of the intracortical inhibitory/facilitatory circuits. The TMS parameters include motor threshold (MT), motor evoke potential, silent period, short intracortical inhibition and facilitation. In single-pulse condition, the stimulation intensity is set at 130% of the MT. While in the paired-pulse condition, the first conditioning stimulus is set at 80% of MT, the second test stimulus is set at 130% of MT.

Secondary Outcome Measures

Variation of walking step time
Subjects are asked to walk on a GAITRite carpet under usual walking speed. Duration between each step can be recorded through the system.
Walking ability
Walking speed, stride length and cadence are recorded as secondary outcome measures. Subjects are asked to walk on a GAITRite carpet under usual walking speed.
Variation of stepping-in-place movement
Subjects are asked to stand and do stepping-in-place movement on a force plate.We use force plate to detect the vertical force and calculate the variation of each step.

Full Information

First Posted
August 6, 2017
Last Updated
March 29, 2019
Sponsor
HsiuYun Chang
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1. Study Identification

Unique Protocol Identification Number
NCT03271736
Brief Title
Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease
Official Title
Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 8, 2018 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
HsiuYun Chang

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
Patients with Parkinson's disease have internal rhythm dysfunction, which may affect the rhythmic movements such as walking. Poor regularity of the rhythmic movement may lead to freezing of gait. This study will apply rhythmic auditory cues on the stepping-in-place training and the investigators will examine if the behavior and neuroelectrophysiology would change after auditory cueing training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical excitability would be modulated after training.
Detailed Description
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. For improving the rhythmic movement problem, auditory cues are often used in clinical setting and shows benefits in ambulation and freezing problems. Previous studies often use finger tapping test and ambulation to assess the rhythmic movement problem. No study uses stepping in place movements as a test to examine rhythmic problem. Little study investigates the effects of auditory cues on brain cortical excitability. In this cross-over study, participants will receive 2 times of training include stepping-in-place exercise with and without auditory cues in random orders. Auditory cues are given via the metronome. There is one-week wash-out period between two trainings. Movement tests such as walking and stepping-in-place and transcranial magnetic stimulation (TMS) are carried out before and after each training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced more, and the cortical excitability would be modulated after the training with auditory cues, comparing with the other training without auditory cues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Auditory cues, step in place, transcranial magnetic stimulation, cortical excitability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Freezer
Arm Type
Experimental
Arm Description
All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.
Arm Title
Non-freezer
Arm Type
Experimental
Arm Description
All the subjects received 2 experiments. 2 experiments contain 20 mins stepping-in-place exercise and pre-/post assessments. The difference between 2 experiments is the application of auditory cues. One of the 2 experiment includes stepping-in-place exercise with auditory cues from the metronome (Stepping-in-place exercise with external auditory cues), in the other experiment we ask the subjects to follow their internal rhythm without external auditory cues (Stepping-in-place exercise without external auditory cues). Transcranial magnetic stimulation (TMS) is applied before and after the stepping-in-place exercise.
Intervention Type
Behavioral
Intervention Name(s)
Stepping-in-place exercise with external auditory cues
Other Intervention Name(s)
Stepping-in-place exercise without external auditory cues
Intervention Description
The stepping-in-place exercise includes 10-session training. In each session, subjects are asked for stepping for 50 steps. In auditory cued condition, the cued frequency is set at 110% of the usual walking cadence. While in non-cued condition, we ask the subjects to step according to their own internal rhythm.
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation (TMS)
Intervention Description
TMS is used to assess the cortical excitability of the motor cortex. The stimulation intensity is set at 130% of the motor threshold in single-pulse condition. In paired-pulse condition, the first stimulus is set at 80% of the motor threshold and the second stimulus is set at 130% of the motor threshold.
Primary Outcome Measure Information:
Title
Changes of transcranial magnetic stimulation (TMS) parameters
Description
Single-pulse and paired-pulse TMS are used to measure the cortical excitability of the motor cortex and the integrity of the intracortical inhibitory/facilitatory circuits. The TMS parameters include motor threshold (MT), motor evoke potential, silent period, short intracortical inhibition and facilitation. In single-pulse condition, the stimulation intensity is set at 130% of the MT. While in the paired-pulse condition, the first conditioning stimulus is set at 80% of MT, the second test stimulus is set at 130% of MT.
Time Frame
TMS parameters are assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.
Secondary Outcome Measure Information:
Title
Variation of walking step time
Description
Subjects are asked to walk on a GAITRite carpet under usual walking speed. Duration between each step can be recorded through the system.
Time Frame
The step time variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.
Title
Walking ability
Description
Walking speed, stride length and cadence are recorded as secondary outcome measures. Subjects are asked to walk on a GAITRite carpet under usual walking speed.
Time Frame
The walking ability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.
Title
Variation of stepping-in-place movement
Description
Subjects are asked to stand and do stepping-in-place movement on a force plate.We use force plate to detect the vertical force and calculate the variation of each step.
Time Frame
The step variability is assessed immediately before and after a 30-minute intervention. The data will be reported through study completion, for average of 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
[Patients with Parkinson's disease] Inclusion Criteria: Diagnosed with idiopathic Parkinson's disease No hearing impairment Able to walk independently for at least 10m Able to follow command (MMSE >=24) [Healthy subjects] No hearing impairment Able to walk independently for at least 10m Able to follow command (MMSE >=24) Exclusion Criteria: With other neurological diseases or psychological diseases Dementia Family history of epilepsy History of head trauma, surgery, or metal implants Having pacemaker or other electrical stimulators History of syncopes or frequent migraines
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau Yih Tsauo, PT, phD
Organizational Affiliation
department of physical therapy, college of medicine, National Taiwan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of physical therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

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