NCT04157582

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
Last Updated

November 8, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

October 26, 2019

Last Update Submit

November 6, 2019

Conditions

Outcome Measures

Primary Outcomes (5)

  • Measuring memory function

    Vienna test system

    45 days

  • Measuring attention

    Vienna test system

    45 days

  • Measuring orientation

    Vienna test system

    45 days

  • Measuring perception

    Vienna test system

    45 days

  • Measuring executive skills

    Vienna test system

    45 days

Study Arms (2)

Study group

EXPERIMENTAL

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 trainingOther: Conventional physical therapy

Control group

EXPERIMENTAL

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

Interventions

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)

Study group

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).

Control groupStudy group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

October 6 university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • October 6 University October 6 University

    October 6 University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raghda Nasr Ibrahim

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer in Neurological Physical Therapy

Study Record Dates

First Submitted

October 26, 2019

First Posted

November 8, 2019

Study Start

October 8, 2019

Primary Completion

October 10, 2021

Study Completion

October 20, 2021

Last Updated

November 8, 2019

Record last verified: 2019-11

Locations