Thoracolumbar Brace for Individuals With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646279
• Other study ID #: 2015/06/7
• Status: Completed
• Phase: N/A
• Start date: September 17, 2015
• Est. completion date: March 31, 2016

Study information

• Verified date: April 2021
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 31, 2016
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	AbiliLife

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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