StrokeNCT06010849
Trunk Control and Extremity Functions in Stroke
An observational study of Stroke, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
The trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. The aim of the study is to examine the relationship of trunk control with balance, upper extremity and lower extremity functions in stroke patients. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 15 Jan 2022
- 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 55 to 85 years
- All sexes
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- -55-85 years old, had an ischemic stroke at least 6 months ago, was at stage 2 according to brunstroma, had a mini-mental test score above 22, could stand independently for 3-4 seconds,
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü Imam University
Kahramanmaraş
About this study
Official title: The Relationship of Trunk Control With Balance, Upper Extremity and Lower Extremity Functions in Stroke Patients
The trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. The aim of the study is to examine the relationship of trunk control with balance, upper extremity and lower extremity functions in stroke patients.
Read the detailed description
Stroke is the third leading cause of death in developed countries after heart disease and cancer. In adults, it ranks first among neurological diseases in terms of causing death and disability.
About one-third of stroke patients experience permanent physical dysfunction. This situation has a negative impact on the economic, social, psychological life and general quality of life of the patient and his family. Stroke is one of the leading causes of long-term disability in adults due to problems such as activity limitations and participation restrictions caused by disorders in body functions . At this point, rehabilitation in stroke patients has an important place in ensuring the social participation of the patient and minimizing the disorders.
When the literature is examined, it is stated that the best functional results are revealed by a good postural control. Because the trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. It provides trunk control, static and dynamic posture, upright posture of the body, and selective trunk movements .
There are many treatment approaches to increase trunk stabilization. Gaining early trunk control is one of the basic principles of Bobath, which adopts the neurodevelopmental behavior model from neurophysiological approaches.
In recent years, core stabilization exercises, which play an active role in trunk stabilization, have started to be included in the rehabilitation program of stroke patients. Haruyama et al. demonstrated the effectiveness of core stabilization exercises on trunk control, standing, and mobility. This study also indicated the importance of trunk stabilization in balance and mobility (5).
Trunk control means more than just sitting balance. Organization of postural and correction reactions, stability required for the creation of extremity movements, rotation, appropriate gait pattern, proximal stabilization to contribute to distal movement, establishment of the connection between shoulder and pelvis are provided by good trunk control. The trunk, which makes up 60% of our body mass, is necessary for controlling the force created in our body and for optimum movement in the extremities. The holistic system that includes the lower extremities, pelvis, trunk and upper extremities is called the kinetic chain. The creation, collection and transfer of the force required for extremity movements from the lower extremity to the upper extremity are made possible by this system. Thus, these segments, which are independent from each other from proximal to distal, work in a certain interaction and harmony during functional activities (6).
The aim of the study is to examine the effect of trunk control on balance, upper extremity and lower extremity functions in stroke patients.
- Conditions
- Stroke
- Being tested
- Trunk control
- Keywords
- Stroke, Trunk Control, Balance, Function
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk controlDiagnostic test
Trunk control
What is being measured
The primary outcome is the main question the study is designed to answer.
The Trunk Impairment Scale
The Trunk Impairment Scale (TIS) consists of 3 parts: 3 items as static sitting balance, 10 items as dynamic sitting balance, and 4 items as coordination. The maximum points received are 7, 10 and 6 points respectively. The total score of TIS is between 0 and 23. High scores indicate good trunk control (6). Turkish validity and reliability study of TIS was also conducted
Measured: at baseline
Berg Balance Scale (BBS)
BBS: It is the gold standard scale that clinically evaluates balance and postural control. It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. If the total score is 56 and above, the balance is considered good.
Measured: at baseline
Fugl meyer lower extremity test
FML: It includes subsections that evaluate hip, knee, ankle joint movements, coordination and reflex activities. The highest score that can be obtained from this assessment is 34.
Measured: at baseline
Fugl meyer upper extremity test
FMU: It includes subsections that evaluate joint movements, coordination and reflex activities related to shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2021
- Primary completion30 Dec 2021
- Study completion15 Jan 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekiye İpek KATIRCI KIRMACI, Kahramanmaras Sutcu Imam University
- Investigators
- zekiye ipek katırcı kırmacı, Principal investigator, kahramanmaras sütçü imam university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010849
- Sponsor's protocol ID
- ipkkrmc
- Status last verified
- Nov 2023
- First submitted
- 21 Aug 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Trunk Control With Balance, Upper Extremity and Lower Extremity Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT06010849
- Acronym / sponsor ID
- ipkkrmc
- Conditions
- Stroke
- Keywords
- Stroke, Trunk Control, Balance, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 25 Aug 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 trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. The aim of the study is to examine the relationship of trunk control with balance, upper extremity and lower extremity functions in stroke patients.
Detailed description
Stroke is the third leading cause of death in developed countries after heart disease and cancer. In adults, it ranks first among neurological diseases in terms of causing death and disability.
About one-third of stroke patients experience permanent physical dysfunction. This situation has a negative impact on the economic, social, psychological life and general quality of life of the patient and his family. Stroke is one of the leading causes of long-term disability in adults due to problems such as activity limitations and participation restrictions caused by disorders in body functions . At this point, rehabilitation in stroke patients has an important place in ensuring the social participation of the patient and minimizing the disorders.
When the literature is examined, it is stated that the best functional results are revealed by a good postural control. Because the trunk is the key point of the body. Proximal trunk control is essential for distal extremity movements, balance and functional activities. It provides trunk control, static and dynamic posture, upright posture of the body, and selective trunk movements .
There are many treatment approaches to increase trunk stabilization. Gaining early trunk control is one of the basic principles of Bobath, which adopts the neurodevelopmental behavior model from neurophysiological approaches.
In recent years, core stabilization exercises, which play an active role in trunk stabilization, have started to be included in the rehabilitation program of stroke patients. Haruyama et al. demonstrated the effectiveness of core stabilization exercises on trunk control, standing, and mobility. This study also indicated the importance of trunk stabilization in balance and mobility (5).
Trunk control means more than just sitting balance. Organization of postural and correction reactions, stability required for the creation of extremity movements, rotation, appropriate gait pattern, proximal stabilization to contribute to distal movement, establishment of the connection between shoulder and pelvis are provided by good trunk control. The trunk, which makes up 60% of our body mass, is necessary for controlling the force created in our body and for optimum movement in the extremities. The holistic system that includes the lower extremities, pelvis, trunk and upper extremities is called the kinetic chain. The creation, collection and transfer of the force required for extremity movements from the lower extremity to the upper extremity are made possible by this system. Thus, these segments, which are independent from each other from proximal to distal, work in a certain interaction and harmony during functional activities (6).
The aim of the study is to examine the effect of trunk control on balance, upper extremity and lower extremity functions in stroke patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (1 listed)
- -55-85 years old, had an ischemic stroke at least 6 months ago, was at stage 2 according to brunstroma, had a mini-mental test score above 22, could stand independently for 3-4 seconds,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Trunk controlTrunk control | Diagnostic test | – |
Primary outcome
The Trunk Impairment Scale
Time frame: at baseline
The Trunk Impairment Scale (TIS) consists of 3 parts: 3 items as static sitting balance, 10 items as dynamic sitting balance, and 4 items as coordination. The maximum points received are 7, 10 and 6 points respectively. The total score of TIS is between 0 and 23. High scores indicate good trunk control (6). Turkish validity and reliability study of TIS was also conducted
Berg Balance Scale (BBS)
Time frame: at baseline
BBS: It is the gold standard scale that clinically evaluates balance and postural control. It is a 14-item scale that measures the ability to maintain balance while performing functional tasks. Each item is scored between 0 and 4. If the total score is 56 and above, the balance is considered good.
Fugl meyer lower extremity test
Time frame: at baseline
FML: It includes subsections that evaluate hip, knee, ankle joint movements, coordination and reflex activities. The highest score that can be obtained from this assessment is 34.
Fugl meyer upper extremity test
Time frame: at baseline
FMU: It includes subsections that evaluate joint movements, coordination and reflex activities related to shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66.
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 28 Nov 2023.
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal 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.
zekiye ipek katırcı kırmacı principal investigator
kahramanmaras sütçü imam 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 Kahramanmaras Sutcu Imam 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 1 inclusion and 0 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 28 Nov 2023. 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?
The Trunk Impairment Scale (time frame: at baseline). The study lists 4 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 28 Nov 2023.