Back to resultsPoised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers
Primary Purpose
Parkinson's Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Poised for Parkinson's
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Alexander Technique, Posture, Mindfulness, Embodiment, Caregivers, Movement Interventions, Complementary Integrative Medicine, Non-pharmacological interventions, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- dyad including care partner and person with Parkinson's disease
- Hoehn & Yahr Stage 2 (estimated)
- vision and hearing (corrected to) normal
- able to use computer, Internet, and Zoom
- ambulatory without assistive devices
- reside in Idaho
Exclusion Criteria:
- dementia (screen with MOCA)
- severe musculoskeletal pain (screen in interview)
Sites / Locations
- Arizona State University
- The Poise Project
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Poised for Parkinson's
Arm Description
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Outcomes
Primary Outcome Measures
Motor Function - objective
Physical Performance Test
Balance - objective
Brief Bestest
Balance: self-report
Activities Balance Confidence scale
Posture - objective
Assessed by photo in sagittal plane
Secondary Outcome Measures
Feasibility - attendance
Course attendance
Feasibility - retention
Study retention
Symptom Management
Survey administered by phone, with Likert scale questions asking how well the person with PD is able to manage typical PD symptoms, including bradykinesia, tremor, stooped posture, freezing of gait, anxiety, fatigue, and so on.
Care-partner self-management skill
Survey administered by phone, with Likert scale questions asking how well the care partner is able to manage the demands of being a care partner to a person with Parkinson's disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04726709
Brief Title
Poised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers
Official Title
Alexander Technique Classes - Multisite
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 27, 2033 (Anticipated)
Study Completion Date
July 27, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Idaho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to develop, deliver, and test an online Alexander-based training program for people with Parkinson's disease and their care partners.
Detailed Description
Six dyads, each consisting of a person with Parkinson's disease and their care partner, will participate in a real-time online course called "Poised for Parkinson's." The course will meet twice per week via Zoom for eighteen 105-minute sessions. Outcome measures, including surveys, interviews, balance, and motor performance, will be assessed the week before classes begin and the week after classes end.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Alexander Technique, Posture, Mindfulness, Embodiment, Caregivers, Movement Interventions, Complementary Integrative Medicine, Non-pharmacological interventions, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poised for Parkinson's
Arm Type
Experimental
Arm Description
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Intervention Type
Behavioral
Intervention Name(s)
Poised for Parkinson's
Intervention Description
Lecture, demonstration, activities, and supplemental materials designed to improve self-awareness, situational awareness, and ability to make good choices for physical and emotional self-care, moment-to-moment.
Primary Outcome Measure Information:
Title
Motor Function - objective
Description
Physical Performance Test
Time Frame
Change between the week before the intervention and the week after the intervention
Title
Balance - objective
Description
Brief Bestest
Time Frame
Change between the week before the intervention and the week after the intervention
Title
Balance: self-report
Description
Activities Balance Confidence scale
Time Frame
Change between the week before the intervention and the week after the intervention
Title
Posture - objective
Description
Assessed by photo in sagittal plane
Time Frame
Change between the week before the intervention and the week after the intervention
Secondary Outcome Measure Information:
Title
Feasibility - attendance
Description
Course attendance
Time Frame
Attendance will be tracked at every class session
Title
Feasibility - retention
Description
Study retention
Time Frame
Change between the week before the intervention and the week after the intervention
Title
Symptom Management
Description
Survey administered by phone, with Likert scale questions asking how well the person with PD is able to manage typical PD symptoms, including bradykinesia, tremor, stooped posture, freezing of gait, anxiety, fatigue, and so on.
Time Frame
Change between the week before the intervention and the week after the intervention
Title
Care-partner self-management skill
Description
Survey administered by phone, with Likert scale questions asking how well the care partner is able to manage the demands of being a care partner to a person with Parkinson's disease
Time Frame
Change between the week before the intervention and the week after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dyad including care partner and person with Parkinson's disease
Hoehn & Yahr Stage 2 (estimated)
vision and hearing (corrected to) normal
able to use computer, Internet, and Zoom
ambulatory without assistive devices
reside in Idaho
Exclusion Criteria:
dementia (screen with MOCA)
severe musculoskeletal pain (screen in interview)
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
The Poise Project
City
Candler
State/Province
North Carolina
ZIP/Postal Code
28715
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual data will be made available on request.
IPD Sharing Time Frame
For five years, starting upon publication
IPD Sharing Access Criteria
upon request: email PI. rcohen@uidaho.edu
Links:
URL
https://www.webpages.uidaho.edu/mindinmovementlab/
Description
The Mind in Movement Lab is conducting this study
URL
https://www.thepoiseproject.org/
Description
The Poise Project is delivering the intervention
Learn more about this trial
Poised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers
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