Clinical trial NCT03271736: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Auditory cues
step in place
transcranial magnetic stimulation
cortical excitability
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes of transcranial magnetic stimulation (TMS) parameters
timeFrame: 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 outcomes:
measure: Variation of walking step time
timeFrame: 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.
measure: Walking ability
timeFrame: 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.
measure: Variation of stepping-in-place movement
timeFrame: 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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of physical therapy, National Taiwan University
Study officials:
affiliation: department of physical therapy, college of medicine, National Taiwan University
name: Jau Yih Tsauo, PT, phD
role: STUDY_CHAIR
References: