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Thoracolumbar Brace for Individuals With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calibrace
Sponsored by
Duquesne University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Parkinson Disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50-80 years of age
  • Diagnosed with Parkinson's Disease
  • Participant self-reports mild difficulty with posture
  • Independent in ambulation without an assistive device (i.e., no walker or cane)
  • Able to give consent determined via telephone screen assessment or at minimum can follow simple directions
  • Able to tolerate 5 minutes of standing or walking at a time per self-report

Exclusion Criteria:

  • Rigid or fixed spine, as determined by self-report and use of thoracolumbar flexibility screen
  • Symptoms present before the age of 50
  • Other neurologic diagnosis, as determined by self-report
  • Spinal surgery
  • Lives in a nursing home or skilled facility
  • Uncorrected vision loss
  • Skin that is sensitive to tape or extremely fragile
  • Recent surgery (within the last 3 months) that affects mobility, as determined by self-report
  • Chest pain at rest or with activity per self report
  • Shortness of breath with daily activity per self report
  • Severe orthostatic hypotension assessed during in-person screen with sitting and standing blood pressure, evidenced by a 20-point drop in systolic blood pressure or 10-point drop in diastolic blood pressure and symptoms (e.g., dizziness) that don't resolve in 5 minutes.
  • High blood pressure 180/110 resting or systolic blood pressure <90 mmHG
  • Resting heart rate > 100 bpm or <50 bpm
  • Waist circumference < 31" or > 51" that would prevent proper fitting of CALIBRACE.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Postural Alignment - Neck Position
    Measured using PostureScreen Mobile Application and all measured bilaterally Neck position measured from (EAM to Acrominom) angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)
    Postural Alignment - Trunk Position
    Measured using PostureScreen Mobile Application and all measured bilaterally Trunk position measure form Acrominom to Greater Trochanter of femur, angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)
    Postural Alignment - Hip/Knee Position
    Measured using PostureScreen Mobile Application and all measured bilaterally Hip/knee position measured from greater trochanter of femur to lateral epicondyle of femur angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)

    Secondary Outcome Measures

    Postural Sway - Center of pressure position
    The mean center of pressure location measured in root mean squared through the average of three trials of eyes open and the average of three trials of eyes closed.
    Postural Sway - Center of pressure velocity
    The mean center of pressure velocity measured in meters/second through the average of three trials of eyes open and the average of three trials of eyes closed.
    Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation
    Survey/interview with seven 4 points Likert-type rating scale (Strongly Disagree, Disagree, Agree, Strongly Agree). High numbers represent more agreement. and three open-ended questions There are no total or subscale scores. The frequency of ratings by participants, by the question is what is reported.

    Full Information

    First Posted
    August 20, 2018
    Last Updated
    April 23, 2021
    Sponsor
    Duquesne University
    Collaborators
    AbiliLife
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03646279
    Brief Title
    Thoracolumbar Brace for Individuals With Parkinson's Disease
    Official Title
    Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 17, 2015 (Actual)
    Primary Completion Date
    March 31, 2016 (Actual)
    Study Completion Date
    March 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duquesne University
    Collaborators
    AbiliLife

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This pilot study looked to see if a new brace would change the way people with Parkinson's Disease positioned their bodies. It also gathered information on the experience of wearing the brace.

    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
    Device Feasibility
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-subject A-B design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Calibrace
    Intervention Description
    The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.
    Primary Outcome Measure Information:
    Title
    Postural Alignment - Neck Position
    Description
    Measured using PostureScreen Mobile Application and all measured bilaterally Neck position measured from (EAM to Acrominom) angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)
    Time Frame
    In a single session, 10 data points per phase were collected
    Title
    Postural Alignment - Trunk Position
    Description
    Measured using PostureScreen Mobile Application and all measured bilaterally Trunk position measure form Acrominom to Greater Trochanter of femur, angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)
    Time Frame
    In a single session, 10 data points per phase were collected
    Title
    Postural Alignment - Hip/Knee Position
    Description
    Measured using PostureScreen Mobile Application and all measured bilaterally Hip/knee position measured from greater trochanter of femur to lateral epicondyle of femur angulation in degrees (flexion values positive/extension values negative) translation in inches (anterior values positive and posterior values negative)
    Time Frame
    In a single session, 10 data points per phase were collected
    Secondary Outcome Measure Information:
    Title
    Postural Sway - Center of pressure position
    Description
    The mean center of pressure location measured in root mean squared through the average of three trials of eyes open and the average of three trials of eyes closed.
    Time Frame
    Single session
    Title
    Postural Sway - Center of pressure velocity
    Description
    The mean center of pressure velocity measured in meters/second through the average of three trials of eyes open and the average of three trials of eyes closed.
    Time Frame
    Single session
    Title
    Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation
    Description
    Survey/interview with seven 4 points Likert-type rating scale (Strongly Disagree, Disagree, Agree, Strongly Agree). High numbers represent more agreement. and three open-ended questions There are no total or subscale scores. The frequency of ratings by participants, by the question is what is reported.
    Time Frame
    Single Session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 50-80 years of age Diagnosed with Parkinson's Disease Participant self-reports mild difficulty with posture Independent in ambulation without an assistive device (i.e., no walker or cane) Able to give consent determined via telephone screen assessment or at minimum can follow simple directions Able to tolerate 5 minutes of standing or walking at a time per self-report Exclusion Criteria: Rigid or fixed spine, as determined by self-report and use of thoracolumbar flexibility screen Symptoms present before the age of 50 Other neurologic diagnosis, as determined by self-report Spinal surgery Lives in a nursing home or skilled facility Uncorrected vision loss Skin that is sensitive to tape or extremely fragile Recent surgery (within the last 3 months) that affects mobility, as determined by self-report Chest pain at rest or with activity per self report Shortness of breath with daily activity per self report Severe orthostatic hypotension assessed during in-person screen with sitting and standing blood pressure, evidenced by a 20-point drop in systolic blood pressure or 10-point drop in diastolic blood pressure and symptoms (e.g., dizziness) that don't resolve in 5 minutes. High blood pressure 180/110 resting or systolic blood pressure <90 mmHG Resting heart rate > 100 bpm or <50 bpm Waist circumference < 31" or > 51" that would prevent proper fitting of CALIBRACE.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    This is not currently a plan to share these data with other researchers.

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    Thoracolumbar Brace for Individuals With Parkinson's Disease

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