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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04157582
Other study ID # 153008
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 8, 2019
Est. completion date October 20, 2021

Study information

Verified date November 2019
Source October 6 University
Contact Raghda Nasr Ibrahim
Phone 01282330479
Email Raghdanassar2020@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 20, 2021
Est. primary completion date October 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates training
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)
Conventional physical therapy
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).

Locations

Country Name City State
Egypt October 6 university Giza

Sponsors (1)

Lead Sponsor Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measuring memory function Vienna test system 45 days
Primary Measuring attention Vienna test system 45 days
Primary Measuring orientation Vienna test system 45 days
Primary Measuring perception Vienna test system 45 days
Primary Measuring executive skills Vienna test system 45 days
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