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Thoracolumbar Brace for Individuals With Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03646279
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : October 10, 2018
Sponsor:
Collaborator:
AbiliLife
Information provided by (Responsible Party):
Duquesne University

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Calibrace Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single-subject A-B design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease
Actual Study Start Date : September 17, 2015
Actual Primary Completion Date : March 31, 2016
Actual Study Completion Date : March 31, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Calibrace
    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 Measures :
  1. Postural Alignment - Neck Position [ Time Frame: In a single session, 10 data points per phase were collected ]

    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)

  2. Postural Alignment - Trunk Position [ Time Frame: In a single session, 10 data points per phase were collected ]

    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)

  3. Postural Alignment - Hip/Knee Position [ Time Frame: In a single session, 10 data points per phase were collected ]

    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 :
  1. Postural Sway - Center of pressure position [ Time Frame: Single session ]
    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.

  2. Postural Sway - Center of pressure velocity [ Time Frame: Single session ]
    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.

  3. Study Developed Survey on the Experience of the Brace [ Time Frame: Single Session ]
    Survey/interview with seven 4 point Likert-type rating scale (Strongly Disagree, Disagree, Agree, Strongly Agree) and three open ended questions



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Duquesne University
ClinicalTrials.gov Identifier: NCT03646279     History of Changes
Other Study ID Numbers: 2015/06/7
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not currently a plan to share these data with other researchers.

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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

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases