StrokeNCT06059482
The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke
An observational study of Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Assessment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2023to 8 Mar 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with stroke
Who may be able to join
- Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
- Over 18 years old,
- Mini-Mental Test score ≥ 24 points,
- Able to sit independently in a chair for 10 minutes
- To be able to understand and follow simple explanations.
Who cannot join
- Having been diagnosed with a brain stem or cerebellar stroke,
- Having neurological or orthopedic pathology,
- Having acute low back pain,
- Having undergone surgery in the last 6 months,
- Having neglect, aphasia and heminanopsis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Merkez, 43100
About this study
The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.
Read the detailed description
Patients who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the "Mini-Mental Test" and "Brunnstrom Upper Extremity Staging" tests, respectively. Then, Trunk Impairment Scale, Trunk Control Test, Function in Sitting Test, and "Fugl Meyer Upper Extremity Test" will be applied respectively.
Thirty patients with stroke will included in the study. Trunk Impairment Scale and Trunk Control Test will used to assess trunk control assessment. Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. Function in Sitting Test will used to assess sitting balance. To evaluate between correlation trunk control and upper extremity and sitting balance will used to correlation analysis tests
- Conditions
- Stroke
- Being tested
- Assessment
- Keywords
- upper extremity, stroke, trunk control, sitting balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Evaluations will be made once.
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
It is a scale developed for the evaluation of the trunk after stroke. It consists of 3 parts:static sitting balance, dynamic sitting balance and coordination. A maximum of 23 points can be obtained, 3 from the static section, 10 from the dynamic section, and 4 from the coordination section.
Except for the coordination part, each part is evaluated bilaterally.
Measured: Baseline (First assessment)
Trunk Control Test
Trunk Control Test is a test developed to evaluate trunk control. It consists of 4 parts. The test consists of the parameters of turning from the supine position to the weak and strong side, coming from the supine position to the sitting position and maintaining the sitting balance. The scoring of each section is 0-12-25. The total score is between 0-100. Higher scores indicate better trunk control of the patient.
Measured: Baseline (First assessment)
Secondary outcomes (2)
Fugl-Meyer Assessment
The Fugl-Meyer Assessment is a disease-specific impairment index designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.The scale consists of four categories (Shoulder/Elbow/Forearm, Wrist, Hand/Finger, and Coordination) and evaluates 23 different movements in 33 sections.The maximum score is 66 points
Measured: Baseline (First assessment)
Function in Sitting Test (FIST)
The FIST is a clinical examination of sitting balance, designed to be conducted at the patient's bedside. Consists of 14 functional, everyday activities as test items. Each item of the test is scored between 0-4. The total score range of FIST is 0-56.
Measured: Baseline (First assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Jul 2023
- Primary completion7 Mar 2024
- Study completion8 Mar 2024
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.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lütfiye AKKURT, PhD, Study director, Kutahya Health Sciences UniversityGüllü A YAGCIOĞLU, PhD, Study chair, Saglik Bilimleri UniversitesiCihan Caner AKSOY, PhD, Study chair, Kutahya Health Sciences UniversityFatıma YAMAN, MD, Study chair, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059482
- Sponsor's protocol ID
- 2023/06-10
- Status last verified
- Jun 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT06059482
- Acronym / sponsor ID
- 2023/06-10
- Conditions
- Stroke
- Keywords
- upper extremity, stroke, trunk control, sitting balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 28 Sep 2023 (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 study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.
Detailed description
Patients who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the "Mini-Mental Test" and "Brunnstrom Upper Extremity Staging" tests, respectively. Then, Trunk Impairment Scale, Trunk Control Test, Function in Sitting Test, and "Fugl Meyer Upper Extremity Test" will be applied respectively.
Thirty patients with stroke will included in the study. Trunk Impairment Scale and Trunk Control Test will used to assess trunk control assessment. Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. Function in Sitting Test will used to assess sitting balance. To evaluate between correlation trunk control and upper extremity and sitting balance will used to correlation analysis tests
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stroke
Key inclusion criteria (5 listed)
- Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
- Over 18 years old,
- Mini-Mental Test score ≥ 24 points,
- Able to sit independently in a chair for 10 minutes
- To be able to understand and follow simple explanations.
Key exclusion criteria (5 listed)
- Having been diagnosed with a brain stem or cerebellar stroke,
- Having neurological or orthopedic pathology,
- Having acute low back pain,
- Having undergone surgery in the last 6 months,
- Having neglect, aphasia and heminanopsis.
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 |
|---|---|---|
| AssessmentEvaluations will be made once. | Other | – |
Primary outcome
Trunk Impairment Scale
Time frame: Baseline (First assessment)
It is a scale developed for the evaluation of the trunk after stroke. It consists of 3 parts:static sitting balance, dynamic sitting balance and coordination. A maximum of 23 points can be obtained, 3 from the static section, 10 from the dynamic section, and 4 from the coordination section. Except for the coordination part, each part is evaluated bilaterally.
Trunk Control Test
Time frame: Baseline (First assessment)
Trunk Control Test is a test developed to evaluate trunk control. It consists of 4 parts. The test consists of the parameters of turning from the supine position to the weak and strong side, coming from the supine position to the sitting position and maintaining the sitting balance. The scoring of each section is 0-12-25. The total score is between 0-100. Higher scores indicate better trunk control of the patient.
2 secondary outcomes
Fugl-Meyer Assessment
Time frame: Baseline (First assessment)
Function in Sitting Test (FIST)
Time frame: Baseline (First assessment)
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 18 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Lütfiye AKKURT, PhD study director
Kutahya Health Sciences University
Güllü A YAGCIOĞLU, PhD study chair
Saglik Bilimleri Universitesi
Cihan Caner AKSOY, PhD study chair
Kutahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kutahya Health Sciences 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 5 inclusion and 5 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 18 Mar 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?
Trunk Impairment Scale (time frame: Baseline (First assessment)). 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 18 Mar 2024.