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Thoracolumbar Brace for Individuals With Parkinson's Disease

D

Duquesne University

Status

Completed

Conditions

Parkinson Disease

Treatments

Device: Calibrace

Study type

Interventional

Funder types

Other

Identifiers

NCT03646279
2015/06/7

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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