Thoracolumbar Brace for Individuals With Parkinson's Disease

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

Patrocinadores

Patrocinador principal: Duquesne University

Colaborador: AbiliLife

Fuente Duquesne University
Resumen breve

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.

Estado general Completed
Fecha de inicio September 17, 2015
Fecha de Terminación March 31, 2016
Fecha de finalización primaria March 31, 2016
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Postural Alignment - Neck Position In a single session, 10 data points per phase were collected
Postural Alignment - Trunk Position In a single session, 10 data points per phase were collected
Postural Alignment - Hip/Knee Position In a single session, 10 data points per phase were collected
Resultado secundario
Medida Periodo de tiempo
Postural Sway - Center of pressure position Single session
Postural Sway - Center of pressure velocity Single session
Study Developed Survey on the Experience of the Brace Single Session
Inscripción 10
Condición
Intervención

Tipo de intervención: Device

Nombre de intervención: Calibrace

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

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: 50 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Fecha de verificación

October 2018

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Datos del paciente No
Información de diseño del estudio

Asignación: N/A

Modelo de intervención: Single Group Assignment

Descripción del modelo de intervención: Single-subject A-B design

Propósito primario: Device Feasibility

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov