NCT03578653

Brief Summary

The full program is focused on identifying and reducing risk factors surrounding falls. Based on previous research, we believe that occupational therapy group classes and adaptive yoga are an ideal pairing to reduce fall risk. The occupational therapy sessions will consist of lecture, group discussion, and activities designed to target biological, behavioral, environmental, and socioeconomic factors that contribute to fall risk specifically for people with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable parkinson-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

July 25, 2019

Status Verified

February 1, 2019

Enrollment Period

7 months

First QC Date

June 13, 2018

Last Update Submit

July 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Fall Risk Factor Management

    Self-report 5 scales measuring the ability to manage fall risk factors

    Baseline, Pre-assessment (8-weeks after baseline), and post-assessment (8-weeks after pre-assessment)

Study Arms (1)

Merging Yoga and Occupational Therapy for Parkinson disease

EXPERIMENTAL

The group participates in three assessment periods: August, October, and December. Then in October-December the group will receive group occupational therapy and recommended community adaptive yoga programming 2x/week for 8 weeks.

Behavioral: Merging Yoga and Occupational Therapy for Parkinson disease

Interventions

The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk. The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.

Merging Yoga and Occupational Therapy for Parkinson disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with a diagnosis of Parkinson's disease OR their care partners
  • Individuals who read and understand English
  • Individuals who can stand with or without an assistive device
  • People who are willing to commit to yoga practice 2x/week for 8 weeks and pay $5/class through Raintree Athletic Club (Scholarships are available if needed!)
  • People who are willing to commit to group occupational therapy 2x/week for 8 weeks free of charge
  • score of at least 4/6 on the short mini mental status exam

You may not qualify if:

  • less than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80521, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Laura Grimm, MS

    Colorado State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2018

First Posted

July 6, 2018

Study Start

June 1, 2018

Primary Completion

December 31, 2018

Study Completion

March 31, 2019

Last Updated

July 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations