Parkinson DiseaseNCT03079817
Proprioception and Meditation
A study testing Yoga Meditation and Proprioceptive Drills in people with Parkinson Disease and Proprioceptive Disorders, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson Disease, Proprioceptive Disorders, Movement Disorders
- What is being tested?
- Yoga Meditation and Proprioceptive Drills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2017to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn \& Yahr stages I-III).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Neruomuscular Research and Active Aging
Coral Gables, Florida, 33147
About this study
Official title: The Effects of Yoga Based Meditation on Proprioception in Individuals With Parkinson's Disease
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.
- Being tested
- Yoga Meditation, Proprioceptive Drills
- Medical subject headings
- Parkinson Disease, Somatosensory Disorders, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga MeditationOther
Yoga meditation using motor imagery to perceive movement patterns
Proprioceptive DrillsOther
Active balance and proprioception drills
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive Drills | Active comparator | 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. Receives: Other: Proprioceptive Drills |
| Yoga Meditation | Experimental | 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. Receives: Other: Yoga Meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 minutes
Tinetti balance and gait.
A subjective evaluation of Balance and gait.
Measured: 3 minutes.
Secondary outcomes (3)
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.
Measured: 60 seconds
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.
Measured: 20 minutes
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start17 Jan 2017
- Primary completion30 Mar 2018
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
- Investigators
- Joseph F Signorile, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079817
- Sponsor's protocol ID
- 20151138
- Status last verified
- Aug 2019
- First submitted
- 8 Mar 2017
- Last updated
- 6 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Yoga Based Meditation on Proprioception in Individuals With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03079817
- Acronym / sponsor ID
- 20151138
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive Drills | Active comparator | Other: Proprioceptive DrillsIncludes 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. |
| Yoga Meditation | Experimental | Other: Yoga MeditationThe 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- An individual must be between 40 and 90 years of age with mild to moderate Parkinson's Disease (Hoehn \& Yahr stages I-III).
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| Yoga MeditationYoga meditation using motor imagery to perceive movement patterns | Other | Yoga Meditation |
| Proprioceptive DrillsActive balance and proprioception drills | Other | Proprioceptive Drills |
Primary outcome
Joint Position Sense
Time frame: 20 minutes
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.
Time frame: 3 minutes.
A subjective evaluation of Balance and gait.
3 secondary outcomes
8ft Up and Go
Time frame: 60 seconds
Joint Kinesthesia
Time frame: 20 minutes
Dynamic Posturography
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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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.
Joseph F Signorile, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Meditation and Proprioceptive Drills in people with Parkinson Disease and Proprioceptive Disorders, run by University of Miami 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 1 inclusion and 7 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 6 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Joint Position Sense (time frame: 20 minutes). The study lists 2 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 NCT03079817, which also lists 2 linked publications.
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 6 Aug 2019.