Parkinson Disease
Conditions
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.
Interventions
DEVICECalibrace
The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.
Sponsors
AbiliLife
Duquesne University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single-subject A-B design
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postural Alignment - Neck Position | In a single session, 10 data points per phase were collected | 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) |
| Postural Alignment - Trunk Position | In a single session, 10 data points per phase were collected | 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) |
| Postural Alignment - Hip/Knee Position | In a single session, 10 data points per phase were collected | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural Sway - Center of pressure position | Single session | 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. |
| Postural Sway - Center of pressure velocity | Single session | 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. |
| Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation | Single Session | 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. |
Outcome results
None listed