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

December 23, 2023 updated by: Rajal Cohen, University of Idaho

Alexander Technique Classes - Multisite

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Candler, North Carolina, United States, 28715
        • The Poise Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Poised for Parkinson's
Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor Function - Objective
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.
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
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.
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
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Attendance
Time Frame: Attendance will be tracked at every class session, weeks 2-10.
Course attendance (out of 16)
Attendance will be tracked at every class session, weeks 2-10.
Feasibility - Retention
Time Frame: assessed after the intervention (week 11)
Study retention: number of participants who completed the study
assessed after the intervention (week 11)
Symptom Management
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.
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
Time Frame: 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.
Assessed after the intervention (week 11)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Idaho

Collaborators

National Institute of General Medical Sciences (NIGMS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2020

Primary Completion (Actual)

August 11, 2021

Study Completion (Actual)

February 23, 2022

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

December 29, 2023

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-164
  • U54GM104944 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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