Trial Outcomes & Findings for Poised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers (NCT NCT04726709)
NCT ID: NCT04726709
Last Updated: 2023-12-29
Results Overview
Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.
Results posted on
2023-12-29
Participant Flow
Recruited through emails to support group leaders, church leaders, offices of aging, and in-person connections from attendance at pre-COVID Parkinson's events.
We did not exclude any enrolled participants. One dyad (two participants) dropped out before initial data collection due to discomfort with technology. Numbers in table refer to participants, not dyads.
Participant milestones
| Measure |
Poised for Parkinson's - Patients
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Poised for Parkinson's - Care Partners
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Poised for Parkinson's - Patients
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Poised for Parkinson's - Care Partners
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Poised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers
Baseline characteristics by cohort
| Measure |
Poised for Parkinson's - Patients
n=16 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
Outcome measures specific to patients include surveys of symptom self-management and objective assessments of physical performance and balance.
|
Poised for Parkinson's - Care Partners
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
Outcome measures specific to care partners include surveys of care recipient symptom self-management.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
69 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
68.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.Population: Participants included people with PD and their care partners. Only people with PD were assessed with objective measures.
Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Motor Function - Objective
|
0.93 score on a scale
Standard Deviation 2.16
|
—
|
PRIMARY outcome
Timeframe: Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.Population: Only participants with PD are included in this assessment.
Due to COVID, we only assessed the subset of brief Bestest that can be scored online: standing on each foot, gait stability, and forward reach. Possible scores: 0-12. Higher score is better. Positive number indicates improvement.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Balance - Objective
|
0.43 score on a scale
Standard Deviation 1.65
|
—
|
PRIMARY outcome
Timeframe: Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.Population: Only people with PD were assessed with this measure.
Activities Balance Confidence scale. Possible score from 0-100. Higher score is better.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Balance: Self-report
|
2.9 score on a scale
Standard Deviation 11.9
|
—
|
PRIMARY outcome
Timeframe: Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.Population: Only participants with PD were assessed.
Assessed by photo in sagittal plane. Positive numbers indicate a more upright posture.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Posture - Objective
|
2.0 degrees
Standard Deviation 6.7
|
—
|
SECONDARY outcome
Timeframe: Attendance will be tracked at every class session, weeks 2-10.Population: people with Parkinson's disease
Course attendance (out of 16)
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Feasibility - Attendance
|
14.2 number of classes attended
Standard Deviation 3.8
|
—
|
SECONDARY outcome
Timeframe: assessed after the intervention (week 11)Population: both participants with PD and care partners
Study retention: number of participants who completed the study
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=16 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
n=14 Participants
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Feasibility - Retention
|
14 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement.Population: self-report from people with PD
Survey administered by phone, with 29 Likert scale questions on a scale of 0-5 asking how well the person with Parkinson's disease is able to manage typical Parkinson's symptoms, including bradykinesia, tremor, stooped posture, freezing of gait, anxiety, fatigue, and so on. Higher scores indicate better symptom management. The scores were summed, with a possible range of 0-145.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=14 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Symptom Management
|
10.14 units on a scale
Standard Deviation 12.20
|
—
|
SECONDARY outcome
Timeframe: Assessed after the intervention (week 11)Population: Only care partners were asked this question.
Anonymous course evaluation survey filled out and mailed in. Question reported: I feel I am better prepared for the present and future daily challenges of being my partner's care partner. Rate from 1-10 with 10 being high.
Outcome measures
| Measure |
Poised for Parkinson's - Patients
n=12 Participants
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
Poised for Parkinson's: 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.
|
Care Partners
People living with Parkinson's disease and their care partners normally attend class together, but it is possible that one might complete the class and the other might not.
|
|---|---|---|
|
Care-partner Self-management Skill
|
8.7 units on a scale
Standard Deviation 1.9
|
—
|
Adverse Events
Poised for Parkinson's - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Poised for Parkinson's - Care Partners
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place