## Protocol Section
### Identification Module
**NCT ID:** NCT03646279

**Brief Title:** Thoracolumbar Brace for Individuals With Parkinson's Disease

**Official Title:** Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease

#### Organization Study ID Info
**ID:** 2015/06/7
#### Organization
**Class:** OTHER
**Full Name:** Duquesne University
### Status Module
#### Completion Date
**Date:** 2016-03-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-27

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-03-31

**Type:** ACTUAL

#### Start Date
**Date:** 2015-09-17

**Type:** ACTUAL

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2018-08-24
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-20
**Study First Submit QC Date:** 2018-08-22
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** AbiliLife

#### Lead Sponsor

**Class:** OTHER

**Name:** Duquesne University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Parkinson Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Single-subject A-B design

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DEVICE_FEASIBILITY

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

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

**Name:** Calibrace

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** Postural Alignment - Neck Position

**Time Frame:** In a single session, 10 data points per phase were collected

**Description:** 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)

**Measure:** Postural Alignment - Trunk Position

**Time Frame:** In a single session, 10 data points per phase were collected

**Description:** 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)

**Measure:** Postural Alignment - Hip/Knee Position

**Time Frame:** In a single session, 10 data points per phase were collected

#### Secondary Outcomes

**Description:** 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.

**Measure:** Postural Sway - Center of pressure position

**Time Frame:** Single session

**Description:** 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.

**Measure:** Postural Sway - Center of pressure velocity

**Time Frame:** Single session

**Description:** 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.

**Measure:** Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation

**Time Frame:** Single Session

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### IPD Sharing Statement Module

**Description:** This is not currently a plan to share these data with other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020734

- Term: Parkinsonian Disorders

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000080874

- Term: Synucleinopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M13213

- Name: Parkinson Disease

- Relevance: HIGH

- As Found: Parkinson's Disease

- ID: M22494

- Name: Parkinsonian Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2217

- Name: Synucleinopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010300

- Term: Parkinson Disease

### Misc Info Module

- Version Holder: 2024-05-24
