search
Back to results

SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease (SegwayPD)

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sensory-Augmented Postural Training
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III) being stable on medication for at least 1 month the ability to stand and walk unsupported for 5 min both on and off medication age between 50 and 85 Exclusion Criteria: neurological disorders other than PD major unstable medical illnesses sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PD - individuals with Parkinson Disease, either male or female

    Arm Description

    Individuals, aged 50-85, with a clinical diagnosis of idiopathic Parkinson Disease, either male or female, with moderate disease stage presenting balance alterations (Hoehn or Yahr stage III)

    Outcomes

    Primary Outcome Measures

    Change from baseline postural sway at week 3
    The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).

    Secondary Outcome Measures

    Feasibility of Segway training
    The attendance of training session for each participant will be used to assess the feasibility of the 1-week postural training. Adherence above 80% will indicate that the participants receive the training well.
    Change from baseline gait spatiotemporal parameters at week 3
    Spatiotemporal parameters will be used to characterized walking in dual task and single task conditions. One gait cycle will be defined as period from heel strike to the consecutive heel strike of the ipsilateral leg. The gait's spatiotemporal parameters obtained from 2 assessments during week 1 will be averaged and used as baseline value. The gait's spatiotemporal parameters obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
    Change from baseline EEG spectral ratio at week 3
    The absolute powers in delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13 - 30 Hz) frequency bands obtained using Fast Fourier Transform will be used to calculate the spectral ratio of the frequency bands. The spectral ratio is defined as ratio of the sum of absolute powers in the alpha and beta bands divided by the sum of the absolute power in the delta and theta frequency bands. The spectral ratio obtained from 2 assessments during week 1 will be averaged and used as baseline value. The spectral ratio obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    September 29, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05982730
    Brief Title
    SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease
    Acronym
    SegwayPD
    Official Title
    SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    July 14, 2025 (Anticipated)
    Study Completion Date
    July 14, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    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 purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD. This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training.
    Detailed Description
    The purpose of this study is to examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control in individuals with PD (Parkinson's disease). This project is a proof-of-concept study to assess the effectiveness of postural training using Segway, which serves a platform to provide augmented and continuous proprioceptive and visuospatial information during postural training. Specifically, we will measure postural sway during quiet standing, single and dual-task walking performances, and brain activation during single and dual-task walking from the regions involved in planning and execution of locomotion; these include dorsolateral prefrontal cortex, premotor cortex and primary motor cortex. The changes in visuospatial function and proprioception after training will also be assessed. Individuals with moderate disease stage of PD exhibiting postural instability will be recruited. The participants will receive 1-week training and be assessed at 3 time points: 1-week before, before, and after the training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PD - individuals with Parkinson Disease, either male or female
    Arm Type
    Experimental
    Arm Description
    Individuals, aged 50-85, with a clinical diagnosis of idiopathic Parkinson Disease, either male or female, with moderate disease stage presenting balance alterations (Hoehn or Yahr stage III)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Sensory-Augmented Postural Training
    Intervention Description
    To examine the safety and efficacy of postural training emphasized on the integration of multiple sensory information into motor control and to assess the effectiveness of postural training using Segway
    Primary Outcome Measure Information:
    Title
    Change from baseline postural sway at week 3
    Description
    The midpoint between the tip of left and right calcaneus bones is considered as the origin of the reference system of the center of pressure (CoP). The CoP displacement along lateral and anterior-posterior axes are measured. The overall size of postural sways will be estimated from the ellipse area conveying 85% of the total CoP samples. The postural sway obtained from 2 assessments during week 1 will be averaged and used as baseline value. The postural sway obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
    Time Frame
    Week 1 (2 assessments), Week 3 (1assessment)
    Secondary Outcome Measure Information:
    Title
    Feasibility of Segway training
    Description
    The attendance of training session for each participant will be used to assess the feasibility of the 1-week postural training. Adherence above 80% will indicate that the participants receive the training well.
    Time Frame
    Week 3 (1 assessment)
    Title
    Change from baseline gait spatiotemporal parameters at week 3
    Description
    Spatiotemporal parameters will be used to characterized walking in dual task and single task conditions. One gait cycle will be defined as period from heel strike to the consecutive heel strike of the ipsilateral leg. The gait's spatiotemporal parameters obtained from 2 assessments during week 1 will be averaged and used as baseline value. The gait's spatiotemporal parameters obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
    Time Frame
    Week 1 (2 assessments), Week 3 (1assessment)
    Title
    Change from baseline EEG spectral ratio at week 3
    Description
    The absolute powers in delta (0.5-4 Hz), theta (4-8 Hz), alpha (8-13 Hz), and beta (13 - 30 Hz) frequency bands obtained using Fast Fourier Transform will be used to calculate the spectral ratio of the frequency bands. The spectral ratio is defined as ratio of the sum of absolute powers in the alpha and beta bands divided by the sum of the absolute power in the delta and theta frequency bands. The spectral ratio obtained from 2 assessments during week 1 will be averaged and used as baseline value. The spectral ratio obtained at week 3 is used to analyze the change from baseline due to training intervention (week 2).
    Time Frame
    Week 1 (2 assessments), Week 3 (1assessment)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a clinical diagnosis of idiopathic PD with moderate disease stage presenting balance alterations (Hoehn and Yahr stage III) being stable on medication for at least 1 month the ability to stand and walk unsupported for 5 min both on and off medication age between 50 and 85 Exclusion Criteria: neurological disorders other than PD major unstable medical illnesses sensory or musculoskeletal disorders (e.g., diabetes, uncorrected visual problems, arthritis, severe hearing impairments) that will prohibit the ability to perform the assessment tests and receive training
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Chen Chung, PT, Ph.D.
    Phone
    214-648-8838
    Email
    yu-chen.chung@utsouthwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Subaryani Soedirdjo, Ph.D.
    Email
    subaryani.soedirdjo@utsouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yasin Dhaher, Ph.D.
    Organizational Affiliation
    University of Texas Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    SegwayPD: The Effect of Sensory-augmented Postural Training Using Segway on Motor and Cognitive Function in Individuals With Parkinson's Disease

    We'll reach out to this number within 24 hrs