Core Stabilization Exercises in Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Core stabilization + Traditional Physical Therapy
Traditional Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, core stabilization, respiratory parameters, balance
Eligibility Criteria
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
Sites / Locations
- Biruni UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Core stabilization + Traditional Physical Therapy
Traditional Physical Therapy
Arm Description
In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group.
This group will continue the traditional physical therapy program.
Outcomes
Primary Outcome Measures
Tiffeneau ratio
Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV₁)/ Forced Vital Capacity (FVC)).
2 Minutes Walking Test
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.
Secondary Outcome Measures
Peak expiratory flow
Spirometric assessment will be performed to determine participants' peak expiratory flow
Chest mobility
It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility.
Trunk Impairment Scale
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.
Timed Up and Go Test
It is used to evaluate dynamic balance and mobility skills.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05549518
Brief Title
Core Stabilization Exercises in Stroke
Official Title
The Effects of Core Stabilization Exercises on Respiratory Functions, Functional Capacity, Trunk Control and Balance in Individuals With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A stroke due to a cerebrovascular accident (CVA) is a neurological deficit characterized by the rapid settlement of signs and symptoms due to focal or global loss of cerebral function, without any apparent cause other than vascular causes. Stroke is one of the most common cardiovascular events in the world. In addition to complications such as spasticity, loss of strength, balance problems, speech and swallowing problems, pulmonary complications are also common in stroke. When the literature is examined, there are a limited number of studies evaluating respiratory functions and functional capacity as a result of core stabilization exercises applied to stroke patients. There is no study in the literature examining the results of core stabilization exercises on respiratory functions, functional capacity, trunk control, and balance in stroke patients. The aim of this study; to investigate the effects of core stabilization training applied in addition to traditional physical therapy on respiratory functions, functional capacity, trunk control, and balance in stroke individuals after cerebrovascular accidents.
Detailed Description
Stroke is a disease that requires rehabilitation practices beyond traditional medical treatments as an approach to managing diseases and complications over time. Physiotherapy and rehabilitation approaches include techniques such as joint range of motion exercises, muscle strengthening, stretching, balance-coordination exercises, neurophysiological approaches (PNF-Bobath), electrical stimulation, orthotic approaches, and breathing exercises. In stroke, especially the lower and upper extremities are emphasized, but trunk dysfunctions are also common. In stroke individuals, weakened trunk muscles cause postural instability, resulting in trunk control disorder, balance problems, and a decrease in physical activity. Decreased trunk control is also associated with decreased pulmonary function and functional capacity. Core Stabilization Exercises (CSE) have recently become a popular form of therapeutic exercise and also play a key role in functional outcomes in stroke individuals. Gradually progressing from easy to difficult, CSE is seen as a critical component of restoring appropriate kinetic function. It is also an exercise approach that aims to prevent compensatory movements, contribute to the motor relearning of inhibited muscles, and strengthen the diaphragm and other respiratory muscles, which are a component of core stability. The aim of this study; to investigate the effects of core stabilization training applied in addition to traditional physical therapy on respiratory functions, functional capacity, trunk control, and balance in stroke individuals after cerebrovascular accidents.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, core stabilization, respiratory parameters, balance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional (Clinical Trial)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Core stabilization + Traditional Physical Therapy
Arm Type
Experimental
Arm Description
In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group.
Arm Title
Traditional Physical Therapy
Arm Type
Active Comparator
Arm Description
This group will continue the traditional physical therapy program.
Intervention Type
Other
Intervention Name(s)
Core stabilization + Traditional Physical Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
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.
Joint range of motion exercises
Stretching exercises
Strengthening exercises
Bobath-based neurophysiological approaches
Task-oriented training
15 minutes of neuromuscular electrical stimulation (NMES) application
Primary Outcome Measure Information:
Title
Tiffeneau ratio
Description
Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV₁)/ Forced Vital Capacity (FVC)).
Time Frame
Change from Baseline Tiffeneau ratio at 6 weeks
Title
2 Minutes Walking Test
Description
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.
Time Frame
Change from Baseline 2 Minutes Walking Test at 6 weeks
Secondary Outcome Measure Information:
Title
Peak expiratory flow
Description
Spirometric assessment will be performed to determine participants' peak expiratory flow
Time Frame
Change from Baseline Peak expiratory flow at 6 weeks
Title
Chest mobility
Description
It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility.
Time Frame
Change from Baseline Chest mobility at 6 weeks
Title
Trunk Impairment Scale
Description
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.
Time Frame
Change from BaselineTrunk Impairment Scale at 6 weeks
Title
Timed Up and Go Test
Description
It is used to evaluate dynamic balance and mobility skills.
Time Frame
Change from Baseline Timed Up and Go Test at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Buket AKINCI, Assoc. Prof.
Phone
+90 409 12 12
Ext
1208
Email
barbuket@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elif Kodaz, PT
Phone
+90 5379929506
Email
201119011@st.biruni.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buket AKINCI, Assoc. Prof.
Organizational Affiliation
Biruni University
Official's Role
Study Chair
Facility Information:
Facility Name
Biruni University
City
Istanbul
ZIP/Postal Code
3400
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Buket AKINCI, Assoc. Prof.
Phone
+90 409 12 12
Ext
1208
Email
barbuket@hotmail.com
First Name & Middle Initial & Last Name & Degree
Elif Kodaz, PT
Phone
+90 5379929506
Email
201119011@st.biruni.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The data will be shared during the publication if the journal will ask.
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Core Stabilization Exercises in Stroke
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