Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104944 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poised for Parkinson's | Experimental | Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poised for Parkinson's | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Function - Objective | Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better. | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
| 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. | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
| Balance: Self-report | Activities Balance Confidence scale. Possible score from 0-100. Higher score is better. | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
| Posture - Objective | Assessed by photo in sagittal plane. Positive numbers indicate a more upright posture. | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Attendance | Course attendance (out of 16) | Attendance will be tracked at every class session, weeks 2-10. |
| Feasibility - Retention | Study retention: number of participants who completed the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Poise Project | Candler | North Carolina | 28715 | United States |
Not provided
| Label | URL |
|---|---|
| The Poise Project is delivering the intervention | View source |
Not provided
Individual data will be made available on request.
For five years, starting upon publication
upon request: email PI. rcohen@uidaho.edu
Not provided
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.
Recruited through emails to support group leaders, church leaders, offices of aging, and in-person connections from attendance at pre-COVID Parkinson's events.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Motor Function - Objective | Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better. | Participants included people with PD and their care partners. Only people with PD were assessed with objective measures. | Posted | Mean | Standard Deviation | score on a scale | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
|
4 months
There were no adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Study conducted during COVID. All assessments conducted via Zoom.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rajal Cohen | University of Idaho | 2088856324 | rcohen@uidaho.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2020 | Oct 5, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2021 | Oct 5, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| assessed after the intervention (week 11) |
| 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. | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
| 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. | Assessed after the intervention (week 11) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Only participants with PD are included in this assessment. | Posted | Mean | Standard Deviation | score on a scale | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
|
|
|
| Primary | Balance: Self-report | Activities Balance Confidence scale. Possible score from 0-100. Higher score is better. | Only people with PD were assessed with this measure. | Posted | Mean | Standard Deviation | score on a scale | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
|
|
|
| Primary | Posture - Objective | Assessed by photo in sagittal plane. Positive numbers indicate a more upright posture. | Only participants with PD were assessed. | Posted | Mean | Standard Deviation | degrees | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
|
|
|
| Secondary | Feasibility - Attendance | Course attendance (out of 16) | people with Parkinson's disease | Posted | Mean | Standard Deviation | number of classes attended | Attendance will be tracked at every class session, weeks 2-10. |
|
|
|
| Secondary | Feasibility - Retention | Study retention: number of participants who completed the study | both participants with PD and care partners | Posted | Count of Participants | Participants | assessed after the intervention (week 11) |
|
|
|
| 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. | self-report from people with PD | Posted | Mean | Standard Deviation | units on a scale | Assessed the week before the intervention (week 1) and the week after the intervention (week 11). Difference is reported. Positive number indicates improvement. |
|
|
|
| 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. | Only care partners were asked this question. | Posted | Mean | Standard Deviation | units on a scale | Assessed after the intervention (week 11) |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |