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Completed

NCT Number: NCT04726709

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Poise Project

Candler, North Carolina, 28715, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Feasibility - Attendance

    Time frame: Attendance will be tracked at every class session, weeks 2-10.

    Course attendance (out of 16)

  2. Feasibility - Retention

    Time frame: assessed after the intervention (week 11)

    Study retention: number of participants who completed the study

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Idaho

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Official study title

Alexander Technique Classes - Multisite

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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