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PC in Stance and During Functional Mobility Following BIG for PD

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LSVT BIG
Sponsored by
University of South Dakota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring postural control, gait

Eligibility Criteria

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

Inclusion Criteria:

  • Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking.

Exclusion Criteria:

  • Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Effect of LSVT BIG therapy on Postural Control and Gait Parameters

    Arm Description

    LSVT BIG is a commonly used protocol to manage functional movement for those with Parkinson's Disease. This study measured postural control and gait parameters following a 4-week course of LSVT BIG therapy.

    Outcomes

    Primary Outcome Measures

    Mini Balance Evaluation Systems Test (Mini-BESTest)
    A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
    Fullerton Advanced Balance Scale (FAB)
    A change in higher level assessment of postural control is assessed.
    Functional and Multidirectional Reach Tests
    A change in proactive postural control strategies is assessed.
    Center of Pressure measures (digitized walkway)
    A change in the limits of stability is assessed.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 28, 2021
    Last Updated
    May 4, 2021
    Sponsor
    University of South Dakota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04877951
    Brief Title
    PC in Stance and During Functional Mobility Following BIG for PD
    Official Title
    Postural Control in Stance and During Functional Mobility Following Management of Parkinson's Disease With LSVT BIG Training
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (Actual)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of South Dakota

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. We are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.
    Detailed Description
    LSVT BIG is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of Parkinson's disease, specifically bradykinesia. Postural instability and gait disturbance is another debilitating feature of Parkinson's disease. While LSVT BIG targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. This study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. Alternative amplitude programs have also been designed to meet the needs of patients with PD. These programs adjust frequencies for patients and individualize sessions more than LSVT BIG. We are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as LSVT BIG in our outcome measures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    postural control, gait

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Effect of LSVT BIG therapy on Postural Control and Gait Parameters
    Arm Type
    Other
    Arm Description
    LSVT BIG is a commonly used protocol to manage functional movement for those with Parkinson's Disease. This study measured postural control and gait parameters following a 4-week course of LSVT BIG therapy.
    Intervention Type
    Behavioral
    Intervention Name(s)
    LSVT BIG
    Intervention Description
    LSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease.
    Primary Outcome Measure Information:
    Title
    Mini Balance Evaluation Systems Test (Mini-BESTest)
    Description
    A change in reactive, proactive, and sensory contributions to postural control (balance) is assessed.
    Time Frame
    Pre-Intervention (baseline) and Post-Intervention (week 5)
    Title
    Fullerton Advanced Balance Scale (FAB)
    Description
    A change in higher level assessment of postural control is assessed.
    Time Frame
    Pre-Intervention (baseline) and Post-Intervention (week 5)
    Title
    Functional and Multidirectional Reach Tests
    Description
    A change in proactive postural control strategies is assessed.
    Time Frame
    Pre-Intervention (baseline) and Post-Intervention (week 5)
    Title
    Center of Pressure measures (digitized walkway)
    Description
    A change in the limits of stability is assessed.
    Time Frame
    Pre-Intervention (baseline) and Post-Intervention (week 5)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects will be included in the study if they have been diagnosed with idiopathic Parkinson's disease and are English speaking. Exclusion Criteria: Exclusion Criteria: 1) previous completion of LSVT BIG or other formal amplitude program training 2) non-idopathic Parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patti J Berg-Poppe, PhD
    Organizational Affiliation
    University of South Dakota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    PC in Stance and During Functional Mobility Following BIG for PD

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