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Effect of Pilates Training on Cognitive Functions in Patients With Stroke

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ClinicalTrials.gov Identifier: NCT04157582
Recruitment Status : Unknown
Verified November 2019 by Raghda Nasr Ibrahim Nasr, October 6 University.
Recruitment status was:  Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Raghda Nasr Ibrahim Nasr, October 6 University

Brief Summary:
The purpose of the present study is to investigate the effect of pilates training on cognitive functions in patient with stroke

Condition or disease Intervention/treatment Phase
Stroke Other: Pilates training Other: Conventional physical therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Pilates Training on Cognitive Functions in Patients With Stroke
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : October 20, 2021

Arm Intervention/treatment
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).
Other: Pilates training
  1. Pilates warm-up training (5 minutes) consisted of Breathing, the Chest stretch, the Toy soldier, Upper extremity PNF patterns, and Roll down.
  2. Pilates mat training performed in 5 different positions (30 minutes).

    1. 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).
    2. Clare, the Side kick, Arm openings, the Lower lift, Leg lifts, and the Side bend were performed in the side-lying position.
    3. Swan dive, the One leg kick, Swimming, the Breast stroke preparations, the Breast stroke performed in the prone position(Fig.8).
    4. Half roll back, Oblique roll up were performed in the sitting position.
    5. Swimming was performed in the kneeling position.
  3. The Pilates cool down training (5 minutes) were the Spine stretch, Saw, Chest stretch, Toy soldier. (Cruz et al .,2011)

Other: Conventional physical therapy
  1. Gentle manual stretching exercises for (elbow flexors, wrist flexors , hamstring and calf muscle).
  2. Strengthening Exercises for ( elbow extensors, wrist extensors and dorsiflexors)
  3. 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).

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 ).
Other: Conventional physical therapy
  1. Gentle manual stretching exercises for (elbow flexors, wrist flexors , hamstring and calf muscle).
  2. Strengthening Exercises for ( elbow extensors, wrist extensors and dorsiflexors)
  3. 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 Measures :
  1. Measuring memory function [ Time Frame: 45 days ]
    Vienna test system

  2. Measuring attention [ Time Frame: 45 days ]
    Vienna test system

  3. Measuring orientation [ Time Frame: 45 days ]
    Vienna test system

  4. Measuring perception [ Time Frame: 45 days ]
    Vienna test system

  5. Measuring executive skills [ Time Frame: 45 days ]
    Vienna test system



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with ischaemic stroke in the domain of the carotid system.
  3. 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).
  4. Duration of illness not less than six months and not more than 18 months.
  5. Spastcity grade (1) according to the Modified aschworth scale (MAS) ( Bohannon and Smith, 1987)(Appendix III).
  6. All patients in the study should be ambulant independently.
  7. Medically and psychologically stable patients.
  8. All patients will approve and sign a consent form (Appendix I).
  9. All patients are litrate.

Exclusion Criteria:

  1. Patients with hemiparesis with motor weakness or incoordination.
  2. Patients with cardiovascular problems (uncontrolled hypertension ,unstable angina ,significant coronary heart disease and or congestive heart failure).
  3. Patients with dementia with score <3 according to Mini cog test(Appendix V). .
  4. Patients with Musculoskeletal problems (deformity or contracture).
  5. Medically unstable and uncooperative patients.
  6. Patients with Moderate and severe obesity (BMI≥ 35 kg/m2).
  7. Patients with depression with score > 8 according to Hamilton depression rating scale (HAM-D) (Appendix VII).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157582


Contacts
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Contact: Raghda Nasr Ibrahim 01282330479 Raghdanassar2020@gmail.com

Locations
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Egypt
October 6 university Recruiting
Giza, Egypt
Contact: October 6 University    0238362496    Pt@o6u.edu.eg   
Sponsors and Collaborators
October 6 University
Investigators
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Principal Investigator: October 6 University October 6 University October 6 University
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Responsible Party: Raghda Nasr Ibrahim Nasr, Assistant Lecturer in Neurological Physical Therapy, October 6 University
ClinicalTrials.gov Identifier: NCT04157582    
Other Study ID Numbers: 153008
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases