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Influence of Autonomy on Motor Learning in People With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autonomy supported learning
Practice with predetermined feedback
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Autonomy, Motor learning, Transcranial magnetic stimulation

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: age above 20-years-old able to follow instructions to perform the tasks (Montreal Cognitive Assessment ≥ 24) no surgery and injury in upper extremities in recent 6 months Exclusion Criteria: other neurological disorders in addition to Parkinson's disease Parkinson's disease dementia symptom of severe tremor in upper extremities (score ≥ 3 in Question 15 to 18 of UPDRS-III) deep brain stimulation or pacemaker implanted medical history of seizure a blood-relative with history of epilepsy unstable medical conditions pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Self-control group

    Yoked group

    Arm Description

    Participants will be able to choose over feedback schedule when practicing finger-pressing trajectory matching task.

    Participants will receive feedback, which was determined by their counterpart in self-control group, with no-choice when practicing finger-pressing trajectory matching task.

    Outcomes

    Primary Outcome Measures

    Performance accuracy
    Overall performance accuracy relative to the target waveform was assessed using root mean square error (RMSE), which is the mean difference between the target waveform and the participant's movement trajectory calculated over their actual movement time.

    Secondary Outcome Measures

    Intrinsic Motivation Inventory
    A questionnaire with subscales of perceived competence and autonomy. Questions were either taken directly or modified from the IMI, regarding to the participants subjective motivation after completing their practice trials.
    Error Estimation
    Participants will be instructed to estimate their error in RMSE after completing each trial in retention and transfer test. Error estimation is used to assess the cognitive processing of participants during the trials.
    Cortical excitability changes
    Transcranial magnetic stimulation (TMS) device (The Magstim Company Ltd, Whitland, UK) will be used to determine the neurophysiological changes of corticomotor excitability before and after the acquisition phase.

    Full Information

    First Posted
    July 17, 2023
    Last Updated
    July 24, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05960331
    Brief Title
    Influence of Autonomy on Motor Learning in People With Parkinson's Disease
    Official Title
    Influence of Autonomy on Motor Learning in People With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to explore the benefits of autonomy supported learning in patients with Parkinson's disease. The main questions to answer are: Whether autonomy supported learning can benefit motor learning in PD patients Whether autonomy supported learning can enhance intrinsic motivation and/ or information processing of PD patients in learning a new task. Whether autonomy supported learning can facilitate cortical excitability change after practicing a new task. Participants will be recruited into two groups (Self-control group, SC; and yoked group, YK) to learn a finger-pressing trajectory matching task Participants in SC group will have choice over feedback schedule during trial practice Participants in YK group will receive feedback with no-choice during trial practice Researchers will compare the retention test performance to see if autonomy supported learning will lead to better learning effect.
    Detailed Description
    Autonomy is the sense of learner to actively participate in determining their own behaviour. The present study aims to investigate whether an autonomy supported practice (with self-controlled feedback) would benefit adults with Parkinson's disease (PD), along with increased intrinsic motivation, information processing and cortical excitability. Two groups of healthy adults and two groups of PD patients will be recruited to learn a finger-pressing trajectory matching task. Participants will be allocated in either a self-control group (choice over feedback schedule), or a yoked group (receive feedback with no-choice). Learning will be assessed on the second day and one week later, along with an error estimation of learners' own performance to represent their information processing ability. Cortical excitability and inhibition will be assessed via transcranial magnetic stimulation as indicators of cortical plasticity. Questionnaire regarding motivation will be assessed before and after practice trials. Study hypothesized that individual with PD would benefit from autonomy supported learning, with better performance, enhanced motivation and information processing, associates with change of cortical excitability

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    Parkinson's disease, Autonomy, Motor learning, Transcranial magnetic stimulation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Self-control group
    Arm Type
    Experimental
    Arm Description
    Participants will be able to choose over feedback schedule when practicing finger-pressing trajectory matching task.
    Arm Title
    Yoked group
    Arm Type
    Active Comparator
    Arm Description
    Participants will receive feedback, which was determined by their counterpart in self-control group, with no-choice when practicing finger-pressing trajectory matching task.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Autonomy supported learning
    Intervention Description
    The ability of learners to participate in determining their own behaviour, which is the feedback schedule regarding their practice performance in this study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Practice with predetermined feedback
    Intervention Description
    Learners practice the motor task, while the feedback is provided according to their counterpartner
    Primary Outcome Measure Information:
    Title
    Performance accuracy
    Description
    Overall performance accuracy relative to the target waveform was assessed using root mean square error (RMSE), which is the mean difference between the target waveform and the participant's movement trajectory calculated over their actual movement time.
    Time Frame
    up to day 7
    Secondary Outcome Measure Information:
    Title
    Intrinsic Motivation Inventory
    Description
    A questionnaire with subscales of perceived competence and autonomy. Questions were either taken directly or modified from the IMI, regarding to the participants subjective motivation after completing their practice trials.
    Time Frame
    day 1, day 2, day 7
    Title
    Error Estimation
    Description
    Participants will be instructed to estimate their error in RMSE after completing each trial in retention and transfer test. Error estimation is used to assess the cognitive processing of participants during the trials.
    Time Frame
    day 2, day 7
    Title
    Cortical excitability changes
    Description
    Transcranial magnetic stimulation (TMS) device (The Magstim Company Ltd, Whitland, UK) will be used to determine the neurophysiological changes of corticomotor excitability before and after the acquisition phase.
    Time Frame
    Baseline, day 2, day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: age above 20-years-old able to follow instructions to perform the tasks (Montreal Cognitive Assessment ≥ 24) no surgery and injury in upper extremities in recent 6 months Exclusion Criteria: other neurological disorders in addition to Parkinson's disease Parkinson's disease dementia symptom of severe tremor in upper extremities (score ≥ 3 in Question 15 to 18 of UPDRS-III) deep brain stimulation or pacemaker implanted medical history of seizure a blood-relative with history of epilepsy unstable medical conditions pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    YA-YUN LEE, PhD
    Phone
    +886-2-33668155
    Email
    yayunlee@ntu.edu.tw
    First Name & Middle Initial & Last Name or Official Title & Degree
    DE-JUN LIM, Bachelor
    Phone
    +886-9-66716146
    Email
    R11428011@ntu.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28224481
    Citation
    Carter MJ, Ste-Marie DM. Not all choices are created equal: Task-relevant choices enhance motor learning compared to task-irrelevant choices. Psychon Bull Rev. 2017 Dec;24(6):1879-1888. doi: 10.3758/s13423-017-1250-7.
    Results Reference
    result
    PubMed Identifier
    22209649
    Citation
    Chiviacowsky S, Wulf G, Lewthwaite R, Campos T. Motor learning benefits of self-controlled practice in persons with Parkinson's disease. Gait Posture. 2012 Apr;35(4):601-5. doi: 10.1016/j.gaitpost.2011.12.003. Epub 2011 Dec 30.
    Results Reference
    result

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    Influence of Autonomy on Motor Learning in People With Parkinson's Disease

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