Thoracolumbar Brace for Individuals With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Calibrace


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Single-subject A-B design
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | In a single session, 10 data points per phase were collected | 
| 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) | In a single session, 10 data points per phase were collected | 
| 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) | In a single session, 10 data points per phase were collected | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Single session | 
| 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. | Single session | 
| 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. | Single Session |