Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04726709
Recruitment Status : Not yet recruiting
First Posted : January 27, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Rajal Cohen, University of Idaho

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Poised for Parkinson's Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alexander Technique Classes - Multisite
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Motor Function - objective [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Physical Performance Test

  2. Balance - objective [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Brief Bestest

  3. Balance: self-report [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Activities Balance Confidence scale

  4. Posture - objective [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Assessed by photo in sagittal plane


Secondary Outcome Measures :
  1. Feasibility - attendance [ Time Frame: Attendance will be tracked at every class session ]
    Course attendance

  2. Feasibility - retention [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Study retention

  3. Symptom Management [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Survey administered by phone, with Likert scale questions asking how well the person with PD is able to manage typical PD symptoms, including bradykinesia, tremor, stooped posture, freezing of gait, anxiety, fatigue, and so on.

  4. Care-partner self-management skill [ Time Frame: Change between the week before the intervention and the week after the intervention ]
    Survey administered by phone, with Likert scale questions asking how well the care partner is able to manage the demands of being a care partner to a person with Parkinson's disease


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726709


Contacts
Layout table for location contacts
Contact: Monika Gross, BFA 828-254-3102 monika.gross@thepoiseproject.org
Contact: Rajal Cohen, PhD 208-885-1073 rcohen@uidaho.edu

Sponsors and Collaborators
University of Idaho
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Rajal Cohen, Associate Professor, University of Idaho
ClinicalTrials.gov Identifier: NCT04726709    
Other Study ID Numbers: 17-164
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual data will be made available on request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: For five years, starting upon publication
Access Criteria: upon request: email PI. rcohen@uidaho.edu

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajal Cohen, University of Idaho:
Alexander Technique
Posture
Mindfulness
Embodiment
Caregivers
 Movement Interventions
Complementary Integrative Medicine
Non-pharmacological interventions
Quality of Life
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases