StrokeNCT05114044
The Effects of Core Stability Training in Chronic Stroke Patients
A study testing Core stability training and Conventional therapy in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Core stability training and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2019to 1 Oct 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First onset
- Stroke duration from 6 months to 2 years
- With ability to cooperate
- Independent ambulation or ambulation with assistive device
Who cannot join
- Uncooperative
- Neglect syndrome
- Surgical history of abdominal and hip region
- Drugs that affect neuromuscular control
- Other neurological disorders
- Serious diseases, unstable medical condition
- BMI ≥ 35
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara
About this study
Official title: The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients
The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.
Read the detailed description
After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.
- Conditions
- Stroke
- Being tested
- Core stability training, Conventional therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stability trainingOther
The core stability training were performed 5 days a week for 15 min over a period of 3 weeks. The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks. Duration of each session was 45 min.
Conventional therapyOther
The conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks. Duration of each session was 45 min
| Study group | Role | What they receive |
|---|---|---|
| Core stability group | Experimental | Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min; 15 min of the session was core stability training, remaining 30 min were conventional therapy. Receives: Other: Core stability training |
| Conventional therapy group | Active comparator | Patients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min of conventional therapy. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline score of Berg Balance Scale at week 3
Berg Balance Scale is reliable and valid tool to assess balance and functional mobility. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Motricity Index Scale for lower extremity at week 3
The Motricity Index was used to measure strength in upper and lower extremities after stroke. Assessing lower extremity strength is a 3 item list with each item consisting of a six point scale ranging from 0 to 33 (0, 9, 14, 19, 25, 33).
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Trunk Control Test at week 3
Trunk Control Test assess four simple aspect of trunk movement. Total score range: 0 to 100.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
6MWT is valid and reliable test to assess walking capacity of stroke patients. The distance that a patient can walk within six minutes is evaluated.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Functional Independence Measure (FIM) at week 3
FIM is valid and reliable scale to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Trunk Impairment Scale (TIS) at week 3
TIS is a tool to assess static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Timed Up and Go Test (TUG) at week 3
TUG test is an assessment tool for measuring mobility in stroke patients. The TUG times a patient standing from a chair, walking 3 metres and returning to sit down.
Measured: Baseline and week 3 (after treatment)
Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3
SS-QOL is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale.
Measured: Baseline and week 3 (after treatment)
Change from baseline measurements Core muscle thickness at week 3
Thickness of five core muscles (rectus abdominis, external oblique, internal oblique, transversus abdominis, multifidus and gluteus medius) are measured by ultrasound. Paretic and nonparetic side of each patient are assessed twice (at baseline and after treatment).
Measured: Baseline and week 3 (after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start19 Jun 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sefa Gümrük Aslan, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114044
- Sponsor's protocol ID
- 23
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 9 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Stability Training on Functional Ability and Muscle Thickness in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05114044
- Acronym / sponsor ID
- 23
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Nov 2021 (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.
The purpose of this study is to assess effects of core stability training on functional ability, balance, gait, motor functions, quality of lite and core muscle thickness of chronic stroke patients.
Detailed description
After being informed about the study all the patients giving written informed consent were assessed. At the beginning the eligible patients were randomized into two groups: core stability and conventional therapy group. The therapy programs were performed 5 times a week for 45 min over a period of 3 weeks. Patients were assessed twice: before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core stability group | Experimental | Other: Core stability trainingPatients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min; 15 min of the session was core stability training, remaining 30 min were conventional therapy. |
| Conventional therapy group | Active comparator | Other: Conventional therapyPatients were performed therapy 5 times a week for 45 min over a period of 3 weeks. The therapy session takes 45 min of conventional therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First onset
- Stroke duration from 6 months to 2 years
- With ability to cooperate
- Independent ambulation or ambulation with assistive device
Key exclusion criteria (7 listed)
- Uncooperative
- Neglect syndrome
- Surgical history of abdominal and hip region
- Drugs that affect neuromuscular control
- Other neurological disorders
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 stability trainingThe core stability training were performed 5 days a week for 15 min over a period of 3 weeks. The conventional therapy were performed 5 days a week for 30 min (remaining time of each session) over a period of 3 weeks. Duration of each session was 45 min. | Other | Core stability group |
| Conventional therapyThe conventional therapy were performed 5 days a week for 45 min over a period of 3 weeks. Duration of each session was 45 min | Other | Conventional therapy group |
Primary outcome
Change from baseline score of Berg Balance Scale at week 3
Time frame: Baseline and week 3 (after treatment)
Berg Balance Scale is reliable and valid tool to assess balance and functional mobility. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Change from baseline score of Motricity Index Scale for lower extremity at week 3
Time frame: Baseline and week 3 (after treatment)
The Motricity Index was used to measure strength in upper and lower extremities after stroke. Assessing lower extremity strength is a 3 item list with each item consisting of a six point scale ranging from 0 to 33 (0, 9, 14, 19, 25, 33).
Change from baseline score of Trunk Control Test at week 3
Time frame: Baseline and week 3 (after treatment)
Trunk Control Test assess four simple aspect of trunk movement. Total score range: 0 to 100.
Change from baseline score of 6 Minute Walk Test (6MWT) at week 3
Time frame: Baseline and week 3 (after treatment)
6MWT is valid and reliable test to assess walking capacity of stroke patients. The distance that a patient can walk within six minutes is evaluated.
Change from baseline score of Functional Independence Measure (FIM) at week 3
Time frame: Baseline and week 3 (after treatment)
FIM is valid and reliable scale to assess and grade the functional status of a person based on the level of assistance he or she requires. FIM is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Change from baseline score of Trunk Impairment Scale (TIS) at week 3
Time frame: Baseline and week 3 (after treatment)
TIS is a tool to assess static and dynamic sitting balance and trunk coordination in a sitting position. On the static and dynamic sitting balance and coordination subscales the maximal scores that can be attained are 7, 10 and 6 points.
Change from baseline score of Timed Up and Go Test (TUG) at week 3
Time frame: Baseline and week 3 (after treatment)
TUG test is an assessment tool for measuring mobility in stroke patients. The TUG times a patient standing from a chair, walking 3 metres and returning to sit down.
Change from baseline score of Stroke Specific Quality of Life Scale (SS-QOL) at week 3
Time frame: Baseline and week 3 (after treatment)
SS-QOL is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Patients must respond to each question of the SS-QOL with reference to the past week. It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale.
Change from baseline measurements Core muscle thickness at week 3
Time frame: Baseline and week 3 (after treatment)
Thickness of five core muscles (rectus abdominis, external oblique, internal oblique, transversus abdominis, multifidus and gluteus medius) are measured by ultrasound. Paretic and nonparetic side of each patient are assessed twice (at baseline and after treatment).
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 9 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 stability training and Conventional therapy in people with Stroke, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital 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 4 inclusion and 7 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 9 Nov 2021. 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?
Change from baseline score of Berg Balance Scale at week 3 (time frame: Baseline and week 3 (after treatment)). The study lists 9 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 9 Nov 2021.