Back to resultsEffect of Pilates Training on Cognitive Functions in Patients With Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Pilates training
Conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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).
Sites / Locations
- October 6 universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study group
Control group
Arm Description
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).
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 ).
Outcomes
Primary Outcome Measures
Measuring memory function
Vienna test system
Measuring attention
Vienna test system
Measuring orientation
Vienna test system
Measuring perception
Vienna test system
Measuring executive skills
Vienna test system
Secondary Outcome Measures
Full Information
NCT ID
NCT04157582
First Posted
October 26, 2019
Last Updated
November 6, 2019
Sponsor
October 6 University
1. Study Identification
Unique Protocol Identification Number
NCT04157582
Brief Title
Effect of Pilates Training on Cognitive Functions in Patients With Stroke
Official Title
Effect of Pilates Training on Cognitive Functions in Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
October 10, 2021 (Anticipated)
Study Completion Date
October 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University
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
The purpose of the present study is to investigate the effect of pilates training on cognitive functions in patient with stroke
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Experimental
Arm Description
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 ).
Intervention Type
Other
Intervention Name(s)
Pilates training
Intervention Description
Pilates warm-up training (5 minutes) consisted of Breathing, the Chest stretch, the Toy soldier, Upper extremity PNF patterns, and Roll down.
Pilates mat training performed in 5 different positions (30 minutes).
One leg stretch, Hundreds, the Double leg stretch, Scissors, the Shoulder bridge, Oblique preparation, and the Hip twist were performed in the supine position(Fig.7).
Clare, the Side kick, Arm openings, the Lower lift, Leg lifts, and the Side bend were performed in the side-lying position.
Swan dive, the One leg kick, Swimming, the Breast stroke preparations, the Breast stroke performed in the prone position(Fig.8).
Half roll back, Oblique roll up were performed in the sitting position.
Swimming was performed in the kneeling position.
The Pilates cool down training (5 minutes) were the Spine stretch, Saw, Chest stretch, Toy soldier. (Cruz et al .,2011)
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
Gentle manual stretching exercises for (elbow flexors, wrist flexors , hamstring and calf muscle).
Strengthening Exercises for ( elbow extensors, wrist extensors and dorsiflexors)
Balance training (Wobble board training) :
Patient will stand on squared then circled wobble board while it moves within parallel bars in front of mirror with hand support(with repetition 10times)
Patient will stand on squared then circled wobble board while it moves within parallel bars in front of mirror without hand support(with repetition 10times).
Primary Outcome Measure Information:
Title
Measuring memory function
Description
Vienna test system
Time Frame
45 days
Title
Measuring attention
Description
Vienna test system
Time Frame
45 days
Title
Measuring orientation
Description
Vienna test system
Time Frame
45 days
Title
Measuring perception
Description
Vienna test system
Time Frame
45 days
Title
Measuring executive skills
Description
Vienna test system
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raghda Nasr Ibrahim
Phone
01282330479
Email
Raghdanassar2020@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
October 6 University October 6 University
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
October 6 University
Phone
0238362496
Email
Pt@o6u.edu.eg
12. IPD Sharing Statement
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Effect of Pilates Training on Cognitive Functions in Patients With Stroke
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