- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157582
Effect of Pilates Training on Cognitive Functions in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke remains a primary cause of morbidity throughout the world mainly because of its effect on cognition. Individuals can recover from physical disability resulting from stroke, but might be unable to return to their previous occupations or independent life because of cognitive impairments.
Post-stroke cognitive impairment is not a unitary syndrome but incorporates a variety of deficits in multiple domains such as attention, executive functions , memory, language and visuoperceptual abilities. Cognitive impairment occurs in up to 64% of people who have had a stroke and has been associated with a 3-fold increase in risk for mortality, institutionalization and decreased instrumental activities of daily living function.
Pilates training was developed by Joseph H. Pilates .It belong to a group of so-called Body-Mind Exercises, where the focus is on controlled movement, posture, and breathing .Pilates (pronounced: puh-lah-teez) improves mental and physical well-being , increases flexibility through controlled movements done as mat exercises.
Pilates training improve cognitive functions through increasing blood and oxygen flow to the brain , support neuronal survival in the developping brain ,Generate new neurons ,Provides mood enhancement ,Increases neurotransmitters and Neurotrophins assure the survival of neurons in areas responsible for learning, memory and higher thinking.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Giza, Egypt
- Recruiting
- October 6 University
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Contact:
- October 6 University
- Phone Number: 0238362496
- Email: Pt@o6u.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Forty patients with stroke (hemiparesis) with muscle power at least grade 3 according to manual muscle testing scale (Appendix VI) from both genders their ages will be ranged from 50-65years old.
- Patients with ischaemic stroke in the domain of the carotid system.
- All patients have mild cognitive deficits in domains ( memory, attention, orientation, perception and executive skills) with score <25 according to Montreal Cognitive Assessment (Appendix IV).
- Duration of illness not less than six months and not more than 18 months.
- Spastcity grade (1) according to the Modified aschworth scale (MAS) ( Bohannon and Smith, 1987)(Appendix III).
- All patients in the study should be ambulant independently.
- Medically and psychologically stable patients.
- All patients will approve and sign a consent form (Appendix I).
- All patients are litrate.
Exclusion Criteria:
- Patients with hemiparesis with motor weakness or incoordination.
- Patients with cardiovascular problems (uncontrolled hypertension ,unstable angina ,significant coronary heart disease and or congestive heart failure).
- Patients with dementia with score <3 according to Mini cog test(Appendix V). .
- Patients with Musculoskeletal problems (deformity or contracture).
- Medically unstable and uncooperative patients.
- Patients with Moderate and severe obesity (BMI≥ 35 kg/m2).
- Patients with depression with score > 8 according to Hamilton depression rating scale (HAM-D) (Appendix VII).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Study group
will consist of 20 hemiparetic patients and will receive Pilates training in addition to conventional physical therapy program consists of (manual stretching exercises, Strengthening Exercises and Wobble board training ) for 18 sessions every other day for one and half month , 3 sessions /week ,each session for 1.30 hours (40 minutes for pilates then 10 minutes rest then 40 minutes conventional physical therapy).
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Experimental: Control group
will consist of 20 hemiparetic patients and will receive conventional physical therapy program only same as group I for 18 sessions every other day for one and half month, 3 sessions /week, each session for (40 minutes ).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measuring memory function
Time Frame: 45 days
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Vienna test system
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45 days
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Measuring attention
Time Frame: 45 days
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Vienna test system
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45 days
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Measuring orientation
Time Frame: 45 days
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Vienna test system
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45 days
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Measuring perception
Time Frame: 45 days
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Vienna test system
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45 days
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Measuring executive skills
Time Frame: 45 days
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Vienna test system
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45 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: October 6 University October 6 University, October 6 University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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