Parkinson's Disease
Conditions
Keywords
Alexander Technique, Posture, Mindfulness, Embodiment, Caregivers, Movement Interventions, Complementary Integrative Medicine, Non-pharmacological interventions, Quality of Life
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.
Interventions
BEHAVIORALPoised 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.
Sponsors
National Institute of General Medical Sciences (NIGMS)
University of Idaho
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Balance: Self-report | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. | Activities Balance Confidence scale. Possible score from 0-100. Higher score is better. |
| Posture - Objective | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. | Assessed by photo in sagittal plane. Positive numbers indicate a more upright posture. |
| Motor Function - Objective | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. | Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better. |
| Balance - Objective | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Attendance | Attendance will be tracked at every class session, weeks 2-10. | Course attendance (out of 16) |
| Feasibility - Retention | assessed after the intervention (week 11) | Study retention: number of participants who completed the study |
| Symptom Management | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. | 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. |
| Care-partner Self-management Skill | Assessed after the intervention (week 11) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruited through emails to support group leaders, church leaders, offices of aging, and in-person connections from attendance at pre-COVID Parkinson's events.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Outcome measures specific to patients include surveys of symptom self-management and objective assessments of physical performance and balance. | 16 |
| 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.
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. | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Poised for Parkinson's - Patients | Poised for Parkinson's - Care Partners | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 9 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 8.4 | 67.6 years STANDARD_DEVIATION 6.7 | 68.3 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 14 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 13 Participants | 27 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 5 Participants | 9 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Balance - Objective
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Balance - Objective | 0.43 score on a scale | Standard Deviation 1.65 |
Primary
Balance: Self-report
Activities Balance Confidence scale. Possible score from 0-100. Higher score is better.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Balance: Self-report | 2.9 score on a scale | Standard Deviation 11.9 |
Primary
Motor Function - Objective
Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Motor Function - Objective | 0.93 score on a scale | Standard Deviation 2.16 |
Primary
Posture - Objective
Assessed by photo in sagittal plane. Positive numbers indicate a more upright posture.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Posture - Objective | 2.0 degrees | Standard Deviation 6.7 |
Secondary
Care-partner Self-management Skill
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.
Time frame: Assessed after the intervention (week 11)
Population: Only care partners were asked this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Care-partner Self-management Skill | 8.7 units on a scale | Standard Deviation 1.9 |
Secondary
Feasibility - Attendance
Course attendance (out of 16)
Time frame: Attendance will be tracked at every class session, weeks 2-10.
Population: people with Parkinson's disease
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Feasibility - Attendance | 14.2 number of classes attended | Standard Deviation 3.8 |
Secondary
Feasibility - Retention
Study retention: number of participants who completed the study
Time frame: assessed after the intervention (week 11)
Population: both participants with PD and care partners
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Poised for Parkinson's - Patients | Feasibility - Retention | 14 Participants |
| Care Partners | Feasibility - Retention | 12 Participants |
Secondary
Symptom Management
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.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Poised for Parkinson's - Patients | Symptom Management | 10.14 units on a scale | Standard Deviation 12.2 |