Back to resultsProprioception and Meditation
Primary Purpose
Parkinson Disease, Proprioceptive Disorders, Movement Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Meditation
Proprioceptive Drills
Sponsored by
About this trial
This is an interventional prevention trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn & Yahr stages I-III).
Exclusion Criteria:
- Participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months
- Participants that have any uncontrolled nerve (except Parkinson's patients taking appropriate medication), bone or joint, or heart disease;
- Participants that have been advised by a doctor to not exercise;
- Participants that have regularly practiced yoga at least twice per week within the past six months;
- Participants that is unable to consent;
- Participants that is a prisoner;
- Participants that are pregnant.
Sites / Locations
- Laboratory of Neruomuscular Research and Active Aging
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Proprioceptive Drills
Yoga Meditation
Arm Description
Includes drills during which participants perform multiplestances on a pillow, a number of different cone and line drills, reaching drills, object retrieval drills and drills using balls to disturb balance.
The meditation program will use simple poses during which the participant will not move and will concentrate on each of the participant's body parts and where they are in space.
Outcomes
Primary Outcome Measures
Joint Position Sense
The joint position sense technique for the knee involves the reduction of visual cues while moving the knee to a specific target angle, holding that target angle, returning the knee to the starting position, and then reproducing that target angle.
Tinetti balance and gait.
A subjective evaluation of Balance and gait.
Secondary Outcome Measures
8ft Up and Go
Individuals sits in a chair at the verbal cue of "go", individual rises from chair and walks as quickly as possible around a cone placed 8 ft from the front of the chair, individual returns to and sits.
Joint Kinesthesia
The Joint Kinesthesia measurement technique involves the participant sitting in the Biodex chair with visual, audio, and tactile cues reduced and the leg supported by an external movement device. The knee is placed at a predetermined angle and slowly flexed or extended at a random starting time while the participant is instructed to signal when movement is felt.
Dynamic Posturography
The participant stands on a randomly moving platform with a sonar emitter affixed to the lumbar spine. As the platform moves the linear and curvilinear displacement of the emitter is evaluated and a dynamic movement analysis core is generated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03079817
Brief Title
Proprioception and Meditation
Official Title
The Effects of Yoga Based Meditation on Proprioception in Individuals With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
In past work is has been shown that yoga can be as effective as a standard balance or Tai Chi protocol; however, there is an inability to distinguish between the mind and body contributions of yoga training. This study will compare an accepted proprioceptive training program to a meditation program which concentrates on body awareness in individuals with Parkinson's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Proprioceptive Disorders, Movement Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proprioceptive Drills
Arm Type
Active Comparator
Arm Description
Includes drills during which participants perform multiplestances on a pillow, a number of different cone and line drills, reaching drills, object retrieval drills and drills using balls to disturb balance.
Arm Title
Yoga Meditation
Arm Type
Experimental
Arm Description
The meditation program will use simple poses during which the participant will not move and will concentrate on each of the participant's body parts and where they are in space.
Intervention Type
Other
Intervention Name(s)
Yoga Meditation
Intervention Description
Yoga meditation using motor imagery to perceive movement patterns
Intervention Type
Other
Intervention Name(s)
Proprioceptive Drills
Intervention Description
Active balance and proprioception drills
Primary Outcome Measure Information:
Title
Joint Position Sense
Description
The joint position sense technique for the knee involves the reduction of visual cues while moving the knee to a specific target angle, holding that target angle, returning the knee to the starting position, and then reproducing that target angle.
Time Frame
20 minutes
Title
Tinetti balance and gait.
Description
A subjective evaluation of Balance and gait.
Time Frame
3 minutes.
Secondary Outcome Measure Information:
Title
8ft Up and Go
Description
Individuals sits in a chair at the verbal cue of "go", individual rises from chair and walks as quickly as possible around a cone placed 8 ft from the front of the chair, individual returns to and sits.
Time Frame
60 seconds
Title
Joint Kinesthesia
Description
The Joint Kinesthesia measurement technique involves the participant sitting in the Biodex chair with visual, audio, and tactile cues reduced and the leg supported by an external movement device. The knee is placed at a predetermined angle and slowly flexed or extended at a random starting time while the participant is instructed to signal when movement is felt.
Time Frame
20 minutes
Title
Dynamic Posturography
Description
The participant stands on a randomly moving platform with a sonar emitter affixed to the lumbar spine. As the platform moves the linear and curvilinear displacement of the emitter is evaluated and a dynamic movement analysis core is generated.
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn & Yahr stages I-III).
Exclusion Criteria:
Participants that have been part of a formal training program that targeted lower body strength, balance or proprioception within the past six months
Participants that have any uncontrolled nerve (except Parkinson's patients taking appropriate medication), bone or joint, or heart disease;
Participants that have been advised by a doctor to not exercise;
Participants that have regularly practiced yoga at least twice per week within the past six months;
Participants that is unable to consent;
Participants that is a prisoner;
Participants that are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph F Signorile, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Neruomuscular Research and Active Aging
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33147
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Proprioception and Meditation
We'll reach out to this number within 24 hrs