Poised for Parkinson's - an Intervention to Increase Embodied Agency in People With Parkinson's Disease and Their Carers

Parkinson's Disease Clinical Trial

Official title:

Alexander Technique Classes - Multisite

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04726709
• Other study ID #: 17-164
• Secondary ID: U54GM104944
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: February 23, 2022

Study information

• Verified date: December 2023
• Source: University of Idaho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 23, 2022
• Est. primary completion date: August 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Poise Project	Candler	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of Idaho	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
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.	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.	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.	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)	Attendance will be tracked at every class session, weeks 2-10.
Secondary	Feasibility - Retention	Study retention: number of participants who completed the study	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.	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.	Assessed after the intervention (week 11)

External Links

•   The Mind in Movement Lab is conducting this study
•   The Poise Project is delivering the intervention