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Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

Primary Purpose

Acoustic Stimulation, Parkinson Disease, Movement, Abnormal

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Upper-limb movement training with the aid of RAS
Upper-limb movement 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria; the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions; a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed; types and doses of medications remain unchanged in the past month right before participation. 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 Type

    Experimental

    Active Comparator

    Arm Label

    the RAS group

    the no-RAS group

    Arm Description

    The RAS group will receive upper-limb movement training with the aid of RAS;

    The no-RAS group will receive upper-limb movement training without the aid of RAS.

    Outcomes

    Primary Outcome Measures

    The box and block test (BBT)
    BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.
    The box and block test (BBT)
    BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.
    The Jebsen hand function test (JHFT)
    JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.
    The Jebsen hand function test (JHFT)
    JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 24, 2022
    Last Updated
    December 12, 2022
    Sponsor
    The Hong Kong Polytechnic University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05637593
    Brief Title
    Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients
    Official Title
    Effects 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
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (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
    The goal of this clinical trial is to examine effects of training involving rhythmic auditory stimulation (RAS) on upper-limb movements and functions in patients with Parkinson's disease (PD). Patients will be randomly divided into two groups: the RAS group and the no-RAS group. Patients will receive training with or without the aid of RAS based on their groups. The training task is to use the right hand to take beads from one bowl to another bowl. The box and block test and the Jebsen hand function test will be used before and after training (i.e., pretest and posttest respectively) to assess patients' upper-limb speed and function. Researchers will compare scores of the box and block test and the Jebsen hand function test between the two groups at pretest and posttest to determine effects of RAS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acoustic Stimulation, Parkinson Disease, Movement, Abnormal, Bradykinesia, Arm

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    the RAS group
    Arm Type
    Experimental
    Arm Description
    The RAS group will receive upper-limb movement training with the aid of RAS;
    Arm Title
    the no-RAS group
    Arm Type
    Active Comparator
    Arm Description
    The no-RAS group will receive upper-limb movement training without the aid of RAS.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Upper-limb movement training with 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 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 21 days.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Upper-limb movement 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 21 days.
    Primary Outcome Measure Information:
    Title
    The box and block test (BBT)
    Description
    BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.
    Time Frame
    One week before the training. BBT requires 2 to 5 minutes to administer.
    Title
    The box and block test (BBT)
    Description
    BBT is used to measure manual dexterity as well as upper-limb movement speed. It is a 53.7* 25.4 cm box separated into two compartments by a 15.2 cm high erected partition, with 150 blocks in each compartment. Starting from the dominant hand, patients will be asked to move the blocks one by one from the compartment on the hand side to the opposite side (e.g., move the blocks from the right compartment to the left compartment for the right hand test). Patients should move the blocks with their arms raised and crossed over the partition. They have one minute to move the blocks as fast as possible. The score of BBT for each hand is the quantity of blocks transferred between compartments in one minute. A higher score indicates faster upper-limb movements and better dexterity. For the elderly, the BBT has high test-retest reliability (intraclass correlation coefficient of 0.89 to 0.97) and construct validity.
    Time Frame
    One week after the training. BBT requires 2 to 5 minutes to administer.
    Title
    The Jebsen hand function test (JHFT)
    Description
    JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.
    Time Frame
    One week before the training. JHFT takes approximately 15 minutes to administer.
    Title
    The Jebsen hand function test (JHFT)
    Description
    JHFT is used to assess unimanual hand function when examinees perform daily activities. Seven items are included in JHFT: writing, turning cards, picking up small objects, simulated feeding, stacking checkers, moving large light objects, and moving large heavy objects. Considering that the patients are Chinese speakers, it is not appropriate to do English writing. According to a previous study conducted in Chinese cultures, the JHFT could be modified through excluding the writing item to avoid cultural influences on scores. The score for each item is the completion time. The less time a patient takes, the better hand function s/he has. The JHFT has excellent test-retest reliability (intraclass correlation coefficients of 0.89 to 0.97) for PD patients.
    Time Frame
    One week after the training. JHFT takes approximately 15 minutes to administer.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: idiopathic PD diagnosed by a neurologist based on the Movement Disorders Society clinical diagnostic criteria; the Hoehn and Yahr stage is 2 or 3, meaning that bilateral movement problems or combination with mild postural instability; a score of Montreal Cognitive Assessment is equal to or higher than 21 to ensure that they understand experimental instructions; a score of Edinburgh Handedness Inventory is above 60 to ensure that they are right-handed; types and doses of medications remain unchanged in the past month right before participation. 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 (supervisor), 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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    Rhythmic Auditory Stimulation on Upper-limb Movements in PD Patients

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