Parkinson's DiseaseNCT04726709

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

A study testing Poised for Parkinson's in people with Parkinson's Disease, run by University of Idaho at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Parkinson's Disease
What is being tested?: Poised for Parkinson's
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 5 Jun 2020to 23 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The Poise Project
Candler, North Carolina, 28715

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Parkinson's Disease
Being tested: Poised for Parkinson's
Keywords: Alexander Technique, Posture, Mindfulness, Embodiment, Caregivers, Movement Interventions, Complementary Integrative Medicine, Non-pharmacological interventions, Quality of Life
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Poised for Parkinson'sBehavioural
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.

Study groups in NCT04726709
Study group	Role	What they receive
Poised for Parkinson's	Experimental	Alexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners. Receives: Behavioral: Poised for Parkinson's

What is being measured

The primary outcome is the main question the study is designed to answer.

Motor Function - Objective
Physical Performance Test (7 items). Score can vary from 0-28. Higher score is better.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Course attendance (out of 16)
Measured: Attendance will be tracked at every class session, weeks 2-10.
Feasibility - Retention
Study retention: number of participants who completed the study
Measured: assessed after the intervention (week 11)
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.
Measured: 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
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.
Measured: Assessed after the intervention (week 11)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202023 Feb 2022

First posted27 Jan 2021
Study start5 Jun 2020
Primary completion11 Aug 2021
Study completion23 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04726709
Sponsor's protocol ID: 17-164
Other IDs: U54GM104944
Status last verified: Dec 2023
First submitted: 12 Jan 2021
Last updated: 29 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual data will be made available on request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Alexander Technique Classes - Multisite
ClinicalTrials.gov ID: NCT04726709
Acronym / sponsor ID: 17-164
Conditions: Parkinson's Disease
Keywords: Alexander Technique, Posture, Mindfulness, Embodiment, Caregivers, Movement Interventions, Complementary Integrative Medicine, Non-pharmacological interventions
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: University of IdahoUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 5 Jun 2020 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 23 Feb 2022 (actual)
First posted: 27 Jan 2021 (actual)
Results: Posted 29 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Poised for Parkinson's	Experimental	Behavioral: Poised for Parkinson'sAlexander-technique-based online course to increase embodied agency in people with Parkinson's disease and their care partners.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Poised for Parkinson'sLecture, 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.	Behavioural	Poised for Parkinson's

Primary outcome

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.
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.
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.
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.

4 secondary outcomes

Feasibility - Attendance
Time frame: Attendance will be tracked at every class session, weeks 2-10.
Feasibility - Retention
Time frame: 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.
Care-partner Self-management Skill
Time frame: Assessed after the intervention (week 11)

Results and safety

Results posted to the registry on 29 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Poised for Parkinson's - Patients	16	14
Poised for Parkinson's - Care Partners	14	12

Primary outcome: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Poised for Parkinson's - Patients n = 14
Value	0.93 (2.16)

Population analysed: Participants included people with PD and their care partners. Only people with PD were assessed with objective measures.

Primary outcome: Balance - Objective

Measure	Poised for Parkinson's n = 14
Value	0.43 (1.65)

Population analysed: Only participants with PD are included in this assessment.

Primary outcome: Balance: Self-report

Measure	Poised for Parkinson's n = 14
Value	2.9 (11.9)

Population analysed: Only people with PD were assessed with this measure.

Primary outcome: Posture - Objective

Measure	Poised for Parkinson's n = 14
Value	2.0 (6.7)

Population analysed: Only participants with PD were assessed.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Poised for Parkinson's - Patients	0 of 16 (0%)	0 of 16 (0%)	0 of 16
Poised for Parkinson's - Care Partners	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): Study conducted during COVID. All assessments conducted via Zoom.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
The Poise Project is delivering the interventionLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual data will be made available on request.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Poised for Parkinson's in people with Parkinson's Disease, run by University of Idaho at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04726709.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.