Thoracolumbar Brace for Individuals With Parkinson's Disease

NCT03646279 | Completed

• 1 other identifier: 2015/06/7
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Postural Sway - Center of pressure position

  Single session

• Postural Sway - Center of pressure velocity

  Single session

• Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation

  Single Session

Interventions

Calibrace DEVICE

The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duquesne University: lead
• AbiliLife: collaborator

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-subject A-B design

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 24, 2018
• Study Start: September 17, 2015
• Primary Completion: March 31, 2016
• Study Completion: March 31, 2016
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share