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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03656796
Collaborator
(none)
29
Enrollment
1
Location
3
Arms
11.3
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Treadmill training with auditory cues
  • Other: Treadmill training without auditory cues
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Rhythmic Auditory Cueing With Locomotion Training on Cortical Excitability and Behavior in Patients With Parkinson's Disease
Actual Study Start Date :
Apr 23, 2018
Actual Primary Completion Date :
Jul 9, 2018
Actual Study Completion Date :
Apr 2, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: PD with freezing of gait (FOG)

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

Other: Treadmill training with auditory cues
Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
Other Names:
  • AC

    • Other: Treadmill training without auditory cues
    Participants should walk in comfortable speed on the treadmill for 30 min.
    Other Names:
  • NC

    		•
    Experimental: PD without freezing of gait (FOG)

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

    Other: Treadmill training with auditory cues
    Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
    Other Names:
  • AC

    • Other: Treadmill training without auditory cues
    Participants should walk in comfortable speed on the treadmill for 30 min.
    Other Names:
  • NC

    		•
    Experimental: Healthy subjects (Control)

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

    Other: Treadmill training with auditory cues
    Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
    Other Names:
  • AC

    • Other: Treadmill training without auditory cues
    Participants should walk in comfortable speed on the treadmill for 30 min.
    Other Names:
  • NC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Transcranial magnetic stimulation (TMS) [40 min]

      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

    1. 10 meter walking test [10 min]

      The foot sensors is used to measure the coefficient of variance of step time (step time CV), gait velocity, stride length, and cadence.

    2. Stepping-in-place test [5 min]

      The foot sensors are used to measure the stepping variability between each step.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Zhong Cheng Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Jer-Junn Luh, PhD, National Taiwan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03656796
    Other Study ID Numbers:
    • 201802068RINC
    First Posted:
    Sep 4, 2018
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Mar 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Taiwan University Hospital
    PD
    Auditory cueing
    TMS
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Sep 25, 2019