StrokeNCT05549518
Core Stabilization Exercises in Stroke
A study testing Core stabilization + Traditional Physical Therapy and Traditional Physical Therapy in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Core stabilization + Traditional Physical Therapy and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Failure to complete the 2 Minute Walking Test
- Having a permanent pacemaker installed
- Having a history of active malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Core Stabilization Exercises on Respiratory Functions, Functional Capacity, Trunk Control and Balance in Individuals With Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Core stabilization + Traditional Physical Therapy, Traditional Physical Therapy
- Keywords
- stroke, core stabilization, respiratory parameters, balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization + Traditional Physical TherapyOther
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.
Traditional Physical TherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Core stabilization + Traditional Physical Therapy | Experimental | In addition to the traditional physical therapy training, core stabilization exercises will be applied in this group. Receives: Other: Core stabilization + Traditional Physical Therapy |
| Traditional Physical Therapy | Active comparator | This group will continue the traditional physical therapy program. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tiffeneau ratio
Spirometric assessment will be performed to determine participants' Tiffeneau ratio (Forced Expiratory Volume 1. second (FEV₁)/ Forced Vital Capacity (FVC)).
Measured: Change from Baseline Tiffeneau ratio at 6 weeks
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.
Measured: Change from Baseline 2 Minutes Walking Test at 6 weeks
Secondary outcomes (4)
Peak expiratory flow
Spirometric assessment will be performed to determine participants' peak expiratory flow
Measured: Change from Baseline Peak expiratory flow at 6 weeks
Chest mobility
It is measured from the axillary, epigastric, and subcostal regions during inhalation and exhalation to assess chest expansion and mobility.
Measured: Change from Baseline Chest mobility at 6 weeks
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.
Measured: Change from BaselineTrunk Impairment Scale at 6 weeks
Timed Up and Go Test
It is used to evaluate dynamic balance and mobility skills.
Measured: Change from Baseline Timed Up and Go Test at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Nov 2022
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket AKINCI, Assoc. Prof., Study chair, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05549518
- Sponsor's protocol ID
- 2015-KAEK-65-22-05
- Status last verified
- Jan 2024
- First submitted
- 15 Sep 2022
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be shared during the publication if the journal will ask.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Stabilization Exercises on Respiratory Functions, Functional Capacity, Trunk Control and Balance in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05549518
- Acronym / sponsor ID
- 2015-KAEK-65-22-05
- Conditions
- Stroke
- Keywords
- stroke, core stabilization, respiratory parameters, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Core stabilization + Traditional Physical Therapy | Experimental | Other: Core stabilization + Traditional Physical TherapyIn addition to the traditional physical therapy training, core stabilization exercises will be applied in this group. |
| Traditional Physical Therapy | Active comparator | Other: Traditional Physical TherapyThis group will continue the traditional physical therapy program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core stabilization + Traditional Physical TherapyIn 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. | Other | Core stabilization + Traditional Physical Therapy |
| Traditional Physical TherapyTraditional 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 | Other | Traditional Physical Therapy |
Primary outcome
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)).
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.
4 secondary outcomes
Peak expiratory flow
Time frame: Change from Baseline Peak expiratory flow at 6 weeks
Chest mobility
Time frame: Change from Baseline Chest mobility at 6 weeks
Trunk Impairment Scale
Time frame: Change from BaselineTrunk Impairment Scale at 6 weeks
Timed Up and Go Test
Time frame: Change from Baseline Timed Up and Go Test at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: Undecided. The data will be shared during the publication if the journal will ask.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buket AKINCI, Assoc. Prof. study chair
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core stabilization + Traditional Physical Therapy and Traditional Physical Therapy in people with Stroke, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tiffeneau ratio (time frame: Change from Baseline Tiffeneau ratio at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.