NCT04726709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

December 29, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.2 years

First QC Date

January 12, 2021

Results QC Date

August 27, 2023

Last Update Submit

December 23, 2023

Conditions

Parkinson's Disease

Keywords

Alexander TechniquePostureMindfulnessEmbodimentCaregiversMovement InterventionsComplementary Integrative MedicineNon-pharmacological interventionsQuality of Life

Outcome Measures

Primary Outcomes (4)

  • 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.

Secondary Outcomes (4)

  • Feasibility - Attendance

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

  • Feasibility - Retention

    assessed after the intervention (week 11)

  • 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.

  • Care-partner Self-management Skill

    Assessed after the intervention (week 11)

Study Arms (1)

Poised for Parkinson's

EXPERIMENTAL

Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.

Behavioral: Poised for Parkinson's

Interventions

Poised for Parkinson'sBEHAVIORAL

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.

Poised for Parkinson's

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • dementia (screen with MOCA)
  • severe musculoskeletal pain (screen in interview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Poise Project

Candler, North Carolina, 28715, United States

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Limitations and Caveats

Study conducted during COVID. All assessments conducted via Zoom.

Results Point of Contact

Title
Dr. Rajal Cohen
Organization
University of Idaho
rcohen@uidaho.edu
2088856324

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 27, 2021

Study Start

June 5, 2020

Primary Completion

August 11, 2021

Study Completion

February 23, 2022

Last Updated

December 29, 2023

Results First Posted

December 29, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Individual data will be made available on request.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
For five years, starting upon publication
Access Criteria
upon request: email PI. rcohen@uidaho.edu

Locations

US(1)