Thoracolumbar Brace for Individuals With Parkinson's Disease

NCT ID: NCT03646279

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-17
• Study Completion Date: 2016-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Interventions

Calibrace

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbiliLife

OTHER

Sponsor Role: collaborator

Duquesne University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2015/06/7

Identifier Type: -

Identifier Source: org_study_id