Parkinson DiseaseNCT03646279
Thoracolumbar Brace for Individuals With Parkinson's Disease
A study testing Calibrace in people with Parkinson Disease, run by Duquesne University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Calibrace
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2015to 31 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
About this study
Official title: Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease
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
- Being tested
- Calibrace
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalibraceDevice
The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Alignment - Neck Position
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)
Measured: In a single session, 10 data points per phase were collected
Postural Alignment - Trunk Position
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)
Measured: In a single session, 10 data points per phase were collected
Postural Alignment - Hip/Knee Position
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)
Measured: In a single session, 10 data points per phase were collected
Secondary outcomes (3)
Postural Sway - Center of pressure position
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.
Measured: Single session
Postural Sway - Center of pressure velocity
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.
Measured: Single session
Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation
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.
Measured: Single Session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start17 Sep 2015
- Primary completion31 Mar 2016
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-subject A-B design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- AbiliLife
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646279
- Sponsor's protocol ID
- 2015/06/7
- Status last verified
- Apr 2021
- First submitted
- 20 Aug 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not currently a plan to share these data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of a Thoracolumbar Brace for Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03646279
- Acronym / sponsor ID
- 2015/06/7
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- AbiliLife
- Study start
- 17 Sep 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Single-subject A-B design
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalibraceThe CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back. | Device | – |
Primary outcome
Postural Alignment - Neck Position
Time frame: 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
Time frame: 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
Time frame: 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)
3 secondary outcomes
Postural Sway - Center of pressure position
Time frame: Single session
Postural Sway - Center of pressure velocity
Time frame: Single session
Researcher Developed Survey on the Experience of the Brace - No Formal Name or Abbreviation
Time frame: Single Session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No. This is not currently a plan to share these data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Calibrace in people with Parkinson Disease, run by Duquesne University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Alignment - Neck Position (time frame: In a single session, 10 data points per phase were collected). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.