- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05549518
Core Stabilization Exercises in Stroke
The Effects of Core Stabilization Exercises on Respiratory Functions, Functional Capacity, Trunk Control and Balance in Individuals With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elif Kodaz, PT
- Phone Number: +90 5379929506
- Email: 201119011@st.biruni.edu.tr
Study Contact Backup
- Name: Buket AKINCI, Assoc. Prof.
- Phone Number: 1208 +90 409 12 12
- Email: barbuket@hotmail.com
Study Locations
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-
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Istanbul, Turkey, 3400
- Biruni University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cerebrovascular attack due to ischemia or hemorrhage
- Over 18 years old and under 65 years old
- Diagnosed with a cerebrovascular attack at least 3 months ago
- A Mini-Mental State Test score of 24 or higher
- Brunnstrom stage 3 or higher in the upper and lower extremities
- 2 or less spasticity according to the Modified Ashworth Scale
- Stage 2 or higher according to the Functional Ambulation Classification
Exclusion Criteria:
- Having a history of additional neurological diseases or disorders other than cerebrovascular attack
- Cerebrovascular attack history more than once
- Having musculoskeletal disorders
- There are other treatments that may alter the effects of the interventions to be applied.
- Having severe aphasia, amnesia, and agnosia
- Having hearing or visual impairment
- Failure to complete the 2 Minute Walking Test
- Having a permanent pacemaker installed
- Having a history of active malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Core stabilization + Traditional Physical Therapy
In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group.
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In addition to the traditional physical therapy training, core stabilization exercises will be applied 3 days a week for 6 weeks, and 20 minutes in each session under the supervision of a physiotherapist. Core stabilization exercises; will gradually progress from easy exercises to difficult ones. Exercises will be performed in supine, hook position, sitting position, on stable and mobile surfaces. Exercises will progress from 1 set to 3 sets, from 7 to 10 reps, contractions from 3 seconds to 10 seconds. All exercises will be performed with breathing control. The exercises will be progressed by gradually increasing them every week. |
Active Comparator: Traditional Physical Therapy
This group will continue the traditional physical therapy program.
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Traditional physical therapy training will be given for 40 minutes each session, 3 times a week for 6 weeks under the supervision of a physiotherapist. As a traditional physical therapy program, a rehabilitation program that increases mobility and daily living activities will be applied to patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tiffeneau ratio
Time Frame: Change from Baseline Tiffeneau ratio at 6 weeks
|
Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV₁)/ Forced Vital Capacity (FVC)).
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Change from Baseline Tiffeneau ratio at 6 weeks
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2 Minutes Walking Test
Time Frame: Change from Baseline 2 Minutes Walking Test at 6 weeks
|
The 2 Minute Walk Test (2MWT) is a measure of self-paced walking ability and functional capacity, particularly for those who cannot manage the longer Six Minute Walk Test (6MWT) or 12 Minute Walk Test.
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Change from Baseline 2 Minutes Walking Test at 6 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peak expiratory flow
Time Frame: Change from Baseline Peak expiratory flow at 6 weeks
|
Spirometric assessment will be performed to determine participants' peak expiratory flow
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Change from Baseline Peak expiratory flow at 6 weeks
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Chest mobility
Time Frame: Change from Baseline Chest mobility at 6 weeks
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It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility.
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Change from Baseline Chest mobility at 6 weeks
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Trunk Impairment Scale
Time Frame: Change from BaselineTrunk Impairment Scale at 6 weeks
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It is used to assess the motor impairment levels of the trunk.
It consists of a total of 17 items under 3 sub-headings: static sitting balance, dynamic sitting balance and trunk coordination.
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Change from BaselineTrunk Impairment Scale at 6 weeks
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Timed Up and Go Test
Time Frame: Change from Baseline Timed Up and Go Test at 6 weeks
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It is used to evaluate dynamic balance and mobility skills.
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Change from Baseline Timed Up and Go Test at 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Buket Akinci, Assoc. Prof., Biruni University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2015-KAEK-65-22-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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