- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063605
The Effect of Clinical Pilates Training on Balance and Postural Control of People With Parkinson's Disease.
March 10, 2021 updated by: European University of Lefke
Many studies showed that clinical pilates exercises has positive effects on static and dynamic balance of different populations.
It was suggested that this type of exercise reduce the risk of falls and physical damage.
It also helps prevention of kyphotic posture.
Parkinson's patients have both balance and postural problems but no study investigated the effect of clinical pilates exercises for this population.
The aim of this study is to investigate the effects of clinical pilates exercise program on postural control and balance in individuals with Parkinson's disease.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patients will be randomly assigned into two groups: Clinical Pilates (CP) Group and Classic Physiotherapy (CF) Group.
Both groups will be treated for 8 weeks.
The evaluation of the patients will be done before the beginning of exercise program and will be repeated at the end.
Static balance of patients will be evaluated with Single Leg Stance Test and Tandem Stance Test, dynamic balance with Functional Reach Test (FRT) and 30 second Chair Stand Test.
Postural control and balance will also be evaluated with Berg Balance Scale and functional capacity by Timed Up and Go Test.
Symptom severity and treatment complications of the patients will be evaluated with United Parkinson's Disease Rating Scale.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mersin, Turkey
- European University of Lefke
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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
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stage 2-3 of Modified Hoehn & Yahr Scale
- 26 or> 26 points from the Mini Mental test
- Having at least 2 years Parkinson Disease
Exclusion Criteria:
- Serious mental and psychological disorder
- Significant musculoskeletal disorders
- Lower extremity deformation
- Having another neurological disease
- Drug or dose change during treatment
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: Clinical Pilates
Participants in this group will receive twice a week, total 8 weeks of clinical pilates exercise program.
Each session will take 45 minutes.
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This exercise model focus on the awareness of the neutral position of the spine and strengthen the deep postural muscles of the spine.
Training of trunk muscles is emphasized and trunk stabilization is achieved and more difficult activities are initiated and thus, body awareness is improved.
There are general principles to be followed during exercises.
These; The principle of concentration is respiration, central focus, control, stability and isolation.
These principles are achieved by simultaneous muscle activation of muscles responsible for trunk stabilization (multifidus, diaphragm, transversus abdominis and pelvic floor muscles).
In order for an exercise to become a clinical pilates exercise, trunk stabilization must be ensured and breath control should be established in each exercise.
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Active Comparator: Classic Physiotherapy
Participants in this group will receive twice a week, total 8 weeks of classic physiotherapy exercise program.
Each session will take 45 minutes.
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This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises.
Aim is to improve muscle strength and prevent shortness of muscles.
Also, balance and gait exercise aim to improve walking capacity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
One leg stance test
Time Frame: 5 minutes
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This test is used to measure balance and standing ability and gives an idea about the individual's ability to balance and the risk of falling.
Test measures how many seconds the patient can stand on one leg.
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5 minutes
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Tandem stance test
Time Frame: 5 minutes
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It is a test that evaluates the static balance by narrowing the ground contact area.
The heel of one foot is adjusted to the end of the other foot.
Patient is asked to try to stand without loss of balance and the time is recorded in seconds.
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5 minutes
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Functional reach test
Time Frame: 5 minutes
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A balance test designed to measure stability limits.
The patient is asked to raise the dominant arm 90 ° and place it at the shoulder level and extend as far as it can go forward, without loss of movement or balance in the feet.
Reduced ability to reach indicates an increased risk of falling in the future.
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5 minutes
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Sit-to-stand test
Time Frame: 5 minutes
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This test evaluates the patient's sit-up activity, lower extremity strength and dynamic balance.
The patient's number of sitting and getting up within 30 seconds gives the test score.
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5 minutes
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Timed-up and Go test
Time Frame: 5 minutes
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When the command is given, the patient gets up from a normal chair, walks 3 meters, turns and walks back to the chair and sits down.
The time starts when the command is given and ends when the person sits back in the chair.
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5 minutes
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Berg Balance Scale
Time Frame: 15 minutes
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This test is used to measure a person's static and dynamic balance performance.
It is effective in assessing postural control and predicting the risk of falling.
It is a 14-item test that uses 0 to 4 sequential scoring for each item.
The total score range is from 0 to 56 and a higher score indicates a better balance.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Beliz Belgen Kaygisiz, PT, PhD, European University of Lefke
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
September 16, 2019
Primary Completion (Actual)
January 21, 2020
Study Completion (Actual)
January 21, 2020
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (Actual)
August 21, 2019
Study Record Updates
Last Update Posted (Actual)
March 12, 2021
Last Update Submitted That Met QC Criteria
March 10, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ÜEK/32/02/03/1819/01 (Other Identifier: European University of Lefke)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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