Thoracolumbar Brace for Individuals With Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT03646279
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-17
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Postural Alignment - Neck Position	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)
Postural Alignment - Trunk Position	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)
Postural Alignment - Hip/Knee Position	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

Name	Time	Method
Postural Sway - Center of pressure position	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.
Postural Sway - Center of pressure velocity	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.
Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation	Single Session	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.