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Completed

NCT Number: NCT03271736

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of physical therapy, National Taiwan University

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

[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

Treatment and study plan

Stepping-in-place exercise with external auditory cues

Behavioral

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.

Other names: Stepping-in-place exercise without external auditory cues

Transcranial Magnetic Stimulation (TMS)

Device

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 outcomes

  1. Changes of transcranial magnetic stimulation (TMS) parameters

    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.

    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 outcomes

  1. Variation of walking step time

    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.

    Subjects are asked to walk on a GAITRite carpet under usual walking speed. Duration between each step can be recorded through the system.

  2. Walking ability

    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.

    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.

  3. Variation of stepping-in-place movement

    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.

    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.

Sponsors and collaborators

Lead sponsor

HsiuYun Chang

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2017
Registry last updated
Apr 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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