- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443752
Comparing the Effectiveness of Shotokan-Karate vs. Tai Chi on Balance and Quality of Life in Parkinson's Disease
February 21, 2018 updated by: Sun Life Financial Movement Disorders Research and Rehabilitation Centre
The following study will be a comparison of balance and quality of life in Tai Chi training programs and Shotokan-Karate training programs in individuals with Parkinson's Disease.
The following study will be a 12-week program which will assess whether or not Shotokan-Karate betters balance and quality of life even more than Tai Chi.
Both Tai Chi and Karate will be taught by a professional instruction at the Sun Life Financial Movement Disorders and Rehabilitation Centre located in Waterloo, Ontario.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Parkinson's disease is a progressive disorder of the central nervous system which affects movement.
Some signs and symptoms of PD include; tremors, rigidity, gait impairments, and balance disruption.
Individuals with PD experience substantially impaired balance ultimately affecting their functional abilities.
With this, individuals with PD may also experience lower quality of life due to these diminished determinants.
Currently, there are medications which have proven to mask the symptoms of Parkinson's such as levodopa.
There are also exercise programs which have proven to improve the symptoms of Parkinson's disease such as resistance based exercises and Tai Chi.based on the proven benefits of balance and overall quality of life through Shotokan-karate training, the purpose of this study will be to compare Shotokan-karate training versus Tai Chi on balance and quality of life in individuals with Parkinson's disease.
Based on the literature available on the benefits of shotokan-karate on balance and quality of life in the elderly, it is hypothesized that shotokan-karate will improve balance and quality of life due to its high intensity, increased engagement and similarities to everyday movements.
If the following hypothesis is supported, the present study will allow for individuals with Parkinson's disease to engage in an exercise program that shows vast improvements in their postural stability and overall quality of life.
In addition, participants will be able to engage in an exercise program which will provide them with long term benefits and they will be able to implement this in their everyday lifestyle.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Eligibility criteria involved a clinical diagnosis of Parkinson's disease, stable medication use, ability to comprehend English, ability to stand without aid and walk with or without assisted aids.
Exclusion Criteria:
- Exclusion criteria for participating in this study included any participation in current studies, which involve behavioural, cognitive or pharmacological interventions. In addition, individuals with impaired vision, impaired behavioural and cognitive abilities, and those who are unable to participate in this study due to unavailability and those with scheduling conflicts will also be apart of the exclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Shotokan-Karate
The protocol for Shotokan-karate training will involve a one hour training session which will be broken down into 3 major components.
The training program will consist of warm-up exercises, katas (choreographed karate movements), and cool-down exercise.
|
The Shotokan-Karate training program will be ran over a period of 12 weeks.
Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario.
The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.
|
Experimental: Tai-Chi
The protocol for Tai Chi will involve a one-hour training session which will be conducted by an instructor at the Sun Life Financial Movement Disorders and Rehabilitation Centre.The following program will be held three times per week.
|
The Tai-Chi training program will be ran over a period of 12 weeks.
Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario.
The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the the Unified Parkinson's Disease Rating Scale (UPDRS)
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Participants will be asked to complete the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS-II) which will be assessed by the supervisor (Quincy J. Almeida).
UPDRS-II will be assessed during the pre-testing period and the post-testing period which will be after the 12 week training program.
UPDRS-II will be reassessed once again after a one month wash out period after the completion of the study.
It will assess the progression of Parkinson's over the course of the exercise program and will look into how the disease has changed over time.
|
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39).
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
PDQ-39 (Parkinson's Disease Questionnaire) is a self-reported questionnaire, which assesses a given individuals quality of life while living with Parkinson's Disease.
The assessment is usually done within the ending of the designated training program.
PDQ-39 assesses the experiences the participant has experienced in the training program (positive or negative), and its impact on the eight quality of life dimensions on specific areas of wellbeing in Parkinson's.
|
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Change in the Timed Up-and-Go (TUG) Test
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
The first condiition in which balance will be measured on individuals with Parkinson's disease will be through the use of the "Timed-up-and-Go" (TUG) Test.
The (TUG) Test is performed on a 4.27m long and 1.22m wide ProtoKinetics Movement Analysis Software^TM electronic walkway carpet (Zeno Walkway- Protokinetics, Haverton, PA, USA) that will capture spatiotemporal aspects of the participant's gait.
The participants will begin the task by sitting on a chair placed on the Zeno Walkway.
Participants will then be asked to stand up and walk to a pylon 3 meters away, then turn around at the pylon and walk back to the chair to sit down.
A stopwatch will be used to record time in which it takes the participants to perform the task.
The Timed Up-and-Go (TUG) Test will measure balance, ability to walk, and the risk of falls in older adults.
|
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Change in the Gait Analysis
Time Frame: Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Change in Gait Analysis will be assessed through the Gait Mat which will measure an individual's step length, stride length, step variability, and the centre of pressure.
Obtained results will be analyzed and calculated through a software which provides results after the completion of each trial.
|
Pre-Test (week prior), Post-Test (after 12-week training program), concluding it with a one month washout period after the completion of the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2018
Primary Completion (Anticipated)
April 3, 2018
Study Completion (Anticipated)
April 25, 2018
Study Registration Dates
First Submitted
January 18, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
February 21, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDRC1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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