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Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

Primary Purpose

Acoustic Stimulation, Parkinson Disease, Electroencephalography

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper-limb training involving RAS
Upper-limb training without the aid of RAS
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acoustic Stimulation focused on measuring Acoustic Stimulation, Parkinson Disease, Movement, Electroencephalography

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria; (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions; (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed; (e) types and doses of medications remain unchanged in the past month right before participation. Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities. Exclusion Criteria: the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    PD-RAS

    PD-noRAS

    HC-RAS

    HC-noRAS

    Arm Description

    training involving RAS

    training without the aid of RAS

    training involving RAS

    training without the aid of RAS

    Outcomes

    Primary Outcome Measures

    Electroencephalography (EEG)
    The power (unit:Watt) of EEG will be calculated.
    Electroencephalography (EEG)
    The power (unit:Watt) of EEG will be calculated.
    Electroencephalography (EEG)
    The power (unit:Watt) of EEG will be calculated.
    Electroencephalography (EEG)
    The functional connectivity (unit:coherence) of EEG will be calculated.
    Electroencephalography (EEG)
    The functional connectivity (unit:coherence) of EEG will be calculated.
    Electroencephalography (EEG)
    The functional connectivity (unit:coherence) of EEG will be calculated.
    The box and block test (BBT)
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    The box and block test (BBT)
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    The box and block test (BBT)
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    The nine hole peg test (NHPT)
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
    The nine hole peg test (NHPT)
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
    The nine hole peg test (NHPT)
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2023
    Last Updated
    March 13, 2023
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05782322
    Brief Title
    Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients
    Official Title
    Effects and Neural Mechanisms of Training Involving Rhythmic Auditory Stimulation on Upper-limb Movements in Patients With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2026 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hong Kong Polytechnic University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Introduction Bradykinesia (i.e., slow movements) is one of the most prominent symptoms of Parkinson's disease (PD) and has a negative impact on quality of life. Rhythmic auditory stimulation (RAS), a widely used and promising treatment technique, has been shown to effectively improve gait speed in PD patients. However, only few studies have explored effects and neural mechanisms of RAS on upper-limb movements. We will conduct two studies to investigate effects and mechanisms of RAS on upper-limb movements in PD patients. The purpose of this study is to examine effects and neural mechanisms of upper-limb movement training involving RAS in PD patients. Methods This study will recruit patients with PD and healthy controls. This study will randomly assign PD patients into two groups: the PD-RAS group and the PD-noRAS group, and healthy controls into the HC-RAS group and the HC-noRAS group. A 7-day upper-limb training involving RAS (for the PD-RAS group and the HC-RAS group) or without RAS (for the PD-noRAS group and the HC-noRAS group) will be provided. EEG and behavioral assessments will be conducted before and after the first day of training, and after the seven-day training program. Two-way repeated measures analysis of variance will be performed to investigate the group and time effects on upper-limb function and neural activity. Study significance The training program will serve as a reference for clinical practitioners who are interested in using RAS in clinical training for PD patients.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acoustic Stimulation, Parkinson Disease, Electroencephalography
    Keywords
    Acoustic Stimulation, Parkinson Disease, Movement, Electroencephalography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD-RAS
    Arm Type
    Experimental
    Arm Description
    training involving RAS
    Arm Title
    PD-noRAS
    Arm Type
    Active Comparator
    Arm Description
    training without the aid of RAS
    Arm Title
    HC-RAS
    Arm Type
    Experimental
    Arm Description
    training involving RAS
    Arm Title
    HC-noRAS
    Arm Type
    Active Comparator
    Arm Description
    training without the aid of RAS
    Intervention Type
    Behavioral
    Intervention Name(s)
    Upper-limb training involving RAS
    Intervention Description
    Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to listen to the RAS sound, use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They should keep their movements consistent with the sound of the RAS, with one RAS sound corresponding to one pick-up movement. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Upper-limb training without the aid of RAS
    Intervention Description
    Three target bowls, labeled as the left, middle, and right target bowl, will be placed on the table at an equal distance from the main bowl. The distance between a target bowl and the main bowl is set at 30 cm. Wooden beads with a diameter of 2 cm will be put in target bowls. The main bowl will be placed in front of the patient. Patients will be asked to use the right hand to take one bead at a time from the left target bowl to the main bowl, repeat this movement for the middle and right target bowls, and keep repeating this order. They are asked to execute the task as fast as possible. Each daily training will consist of three rounds separated by two 5-minute breaks. Each round will consist of four consecutive sessions (for each session: 2-minute training followed by a 30-second break). The training will last for a total of 7 days.
    Primary Outcome Measure Information:
    Title
    Electroencephalography (EEG)
    Description
    The power (unit:Watt) of EEG will be calculated.
    Time Frame
    Assessments will be performed before the first day of training.
    Title
    Electroencephalography (EEG)
    Description
    The power (unit:Watt) of EEG will be calculated.
    Time Frame
    Assessments will be performed after the first day of training.
    Title
    Electroencephalography (EEG)
    Description
    The power (unit:Watt) of EEG will be calculated.
    Time Frame
    Assessments will be performed after the seven-day training program.
    Title
    Electroencephalography (EEG)
    Description
    The functional connectivity (unit:coherence) of EEG will be calculated.
    Time Frame
    Assessments will be performed before the first day of training.
    Title
    Electroencephalography (EEG)
    Description
    The functional connectivity (unit:coherence) of EEG will be calculated.
    Time Frame
    Assessments will be performed after the first day of training.
    Title
    Electroencephalography (EEG)
    Description
    The functional connectivity (unit:coherence) of EEG will be calculated.
    Time Frame
    Assessments will be performed after the seven-day training program.
    Title
    The box and block test (BBT)
    Description
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    Time Frame
    Assessments will be performed before the first day of training.
    Title
    The box and block test (BBT)
    Description
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    Time Frame
    Assessments will be performed after the first day of training.
    Title
    The box and block test (BBT)
    Description
    The BBT is used to measure gross manual dexterity as well as upper-limb movement speed.
    Time Frame
    Assessments will be performed after the seven-day training program.
    Title
    The nine hole peg test (NHPT)
    Description
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
    Time Frame
    Assessments will be performed before the first day of training.
    Title
    The nine hole peg test (NHPT)
    Description
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
    Time Frame
    Assessments will be performed after the first day of training.
    Title
    The nine hole peg test (NHPT)
    Description
    The NHPT is a widely used measure of hand dexterity in a broad range of ages and populations.
    Time Frame
    Assessments will be performed after the seven-day training program.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: (a) idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria; (b) the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; (c) a score of Montreal Cognitive Assessment (MoCA) is equal to or higher than 21 to ensure that they understand experimental instructions; (d) a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed; (e) types and doses of medications remain unchanged in the past month right before participation. Age- and sex-matched healthy controls who filled the criteria (c) and (d) will be recruited from communities. Exclusion Criteria: the presence of medical conditions or diseases that may affect hand movements, vision, or hearing based on self-report.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei FAN (PhD student), MSc
    Phone
    +825 67681229
    Email
    21037721r@connect.polyu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shu-Mei Wang, PhD
    Phone
    +852 27664197
    Email
    shumei.wang@polyu.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei FAN (PhD student), MSc
    Organizational Affiliation
    The Hong Kong Polytechnic University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Effects and Mechanisms of RAS Training on Upper-limb Movements in PD Patients

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