StrokeNCT05244850
The Relationship of Trunk Control With Lower Extremity Sense, Balance and Gait in Stroke
An observational study of Stroke, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Cerebrovascular accident 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Test
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Jun 2021
- 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 30 to 85 years
- All sexes
- Adult, Older adult
Study population: Stroke Patients
Who may be able to join
- Able to walk 10 m without physical assistance,
- Lower extremity functions are in stages 2-6 according to Brunnstrom motor recovery stages,
- At least 3 days and at most 24 months have passed since the stroke,
- Stroke individuals with a score of 7 or higher on the Hodkinson Mental score
Who cannot join
- Having neurological and orthopedic problems that may affect walking other than stroke,
- Having a history of cardiovascular and rheumatological diseases that prevent daily activities,
- Lesion or fracture in the lower extremity,
- Lower extremity spasticity 4 according to the modified Ashworth Scale,
- Individuals with aphasia and communication disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sutcu Imam University
Kahramanmaraş
About this study
Cerebrovascular accident 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. Movement disorder is one of the most common symptoms of stroke, and people with stroke often have trouble falling while walking after they are discharged from the hospital. Therefore, one of the main goals of stroke rehabilitation is to regain independent mobility with a safe and stable gait pattern. In addition to all these, one of the problems faced by most stroke patients is sensory-perception disorders. Sensory impairment can be experienced as the inability to perceive the senses or the inability to distinguish the senses. It should be considered that sensory awareness decreases as more than one sensory impulse competes with each other at the same time, and this situation should not be ignored during the evaluation. Although motor movement is governed by the normal motor field, the adjustment of our position in space is entirely the task of the sensory field. It is not possible to initiate and coordinate movement without sensory control. Since environmental change cannot be perceived during movement, it is not possible to provide environmental adaptation.
Read the detailed description
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. Studies have emphasized the importance of intensive rehabilitation therapy targeting trunk control after stroke. Several randomized controlled trials have looked at the effects of trunk exercises in people with stroke. Saeys and colleagues have shown that the effects of trunk exercises improve standing balance and mobility as well as trunk performance.
There are only a few clinical assessment tools in the literature to evaluate trunk performance. The Trunk Disorder Scale examines static and dynamic sitting balance and trunk coordination. "Postural Assessment Scale for Stroke Patients" (PASS) was developed to evaluate postural control and balance in detail in stroke patients. This scale helps to evaluate postural control and balance of stroke patients, to predict prognosis, to shape treatment, and to observe time-dependent development.
In the literature, the rate of sensory problems accompanying stroke is given differently. In the study conducted by Kim and Choi-Kwon in 67 individuals with acute stroke, two-point discrimination, localization identification, position sense, and stereognosis senses were evaluated and it was found that these senses were affected in 85% of the individuals. In another study, it was stated that sensory impairment in the lower extremities affected gait speed, gait symmetry, standing and walking balance.
However, the relationship between trunk control and lower extremity sense of stroke individuals has not been examined in the literature. In addition, studies on balance and walking have not been sufficiently observed.
- Conditions
- Stroke
- Being tested
- Test
- Keywords
- trunk control, balance, Lower extremity sense
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestOther
Measurements
| Study group | Role | What they receive |
|---|---|---|
| One group | Stroke patients Receives: Other: Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
The Trunk Impairment Scale consists of 3 subscales: static sitting balance (3 items), dynamic sitting balance (10 items) and coordination (4 items). The maximum score of the owner is 7, 10 and 6 points respectively. The Total Trunk Impairment Scale score ranges from 0 to 23, with higher scores indicating better trunk control.
Measured: At baseline
Tinetti Balance and Gait Test
It consists of two parts, walking and balance. Consisting of 16 questions in total, the scale consists of 9 questions in which balance is evaluated first, followed by 7 questions in which gait is evaluated. The total score obtained by the evaluated participant from the first 9 questions constitutes the balance score, and the total score obtained from the following 7 questions constitutes the walking score. 2 points means that the requested task was done correctly, 1 point means that the task was done with adaptations, and 0 points means that the desired task could not be done. A total test score of 18 or less indicates a high fall risk, a moderate fall risk of 19-24 points, and a low-level fall risk with a score above 24.
Measured: At baseline
Ten Meter Walking Test
During the test, the patient walks at a normal walking pace for a distance of 10 meters and the time is recorded.
Measured: At baseline
Fugl Mayer Assesment of Sensorimotor Function
The sensory subscale of FMA (FMA-S) consists of 12 sub-parameters; 4 items are for light touch and 8 items are for proprioception sense. Scoring is between 0-24 points. The light touch sensation is subjectively tested. Joint position is tested on the thumb, wrist, elbow, and interphalangeal joint of the glenohumeral joint. Position sense of the lower extremities is tested on the toe, ankle, knee and hip joint.
Measured: At baseline
Secondary outcomes (1)
Turkish version of Postural Assessment Scale for Stroke Patients (PASS-T)
PASS is a special scale used to measure balance even in stroke patients with very low physical performance. The PASS includes 12 items that measure a person's balance performance in situations where the degree of difficulty is different, that is, when changing positions while lying, sitting, standing or standing. The scale is evaluated between 0-36. Between 0-3, the feasibility of the movement is tested; "0" is the lowest; "3" is the highest value.
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 posted17 Feb 2022
- Study start15 Jan 2021
- Primary completion1 Jun 2021
- Study completion15 Jun 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 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 İpek Katırcı Kırmacı, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244850
- Sponsor's protocol ID
- ipekkkkirmaci
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Trunk Control With Lower Extremity Sense, Balance and Gait in Stroke
- ClinicalTrials.gov ID
- NCT05244850
- Acronym / sponsor ID
- ipekkkkirmaci
- Conditions
- Stroke
- Keywords
- trunk control, balance, Lower extremity sense
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 17 Feb 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.
Cerebrovascular accident 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. Movement disorder is one of the most common symptoms of stroke, and people with stroke often have trouble falling while walking after they are discharged from the hospital. Therefore, one of the main goals of stroke rehabilitation is to regain independent mobility with a safe and stable gait pattern. In addition to all these, one of the problems faced by most stroke patients is sensory-perception disorders. Sensory impairment can be experienced as the inability to perceive the senses or the inability to distinguish the senses. It should be considered that sensory awareness decreases as more than one sensory impulse competes with each other at the same time, and this situation should not be ignored during the evaluation. Although motor movement is governed by the normal motor field, the adjustment of our position in space is entirely the task of the sensory field. It is not possible to initiate and coordinate movement without sensory control. Since environmental change cannot be perceived during movement, it is not possible to provide environmental adaptation.
Detailed description
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. Studies have emphasized the importance of intensive rehabilitation therapy targeting trunk control after stroke. Several randomized controlled trials have looked at the effects of trunk exercises in people with stroke. Saeys and colleagues have shown that the effects of trunk exercises improve standing balance and mobility as well as trunk performance.
There are only a few clinical assessment tools in the literature to evaluate trunk performance. The Trunk Disorder Scale examines static and dynamic sitting balance and trunk coordination. "Postural Assessment Scale for Stroke Patients" (PASS) was developed to evaluate postural control and balance in detail in stroke patients. This scale helps to evaluate postural control and balance of stroke patients, to predict prognosis, to shape treatment, and to observe time-dependent development.
In the literature, the rate of sensory problems accompanying stroke is given differently. In the study conducted by Kim and Choi-Kwon in 67 individuals with acute stroke, two-point discrimination, localization identification, position sense, and stereognosis senses were evaluated and it was found that these senses were affected in 85% of the individuals. In another study, it was stated that sensory impairment in the lower extremities affected gait speed, gait symmetry, standing and walking balance.
However, the relationship between trunk control and lower extremity sense of stroke individuals has not been examined in the literature. In addition, studies on balance and walking have not been sufficiently observed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One group | – | Other: TestStroke patients |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Stroke Patients
Key inclusion criteria (4 listed)
- Able to walk 10 m without physical assistance,
- Lower extremity functions are in stages 2-6 according to Brunnstrom motor recovery stages,
- At least 3 days and at most 24 months have passed since the stroke,
- Stroke individuals with a score of 7 or higher on the Hodkinson Mental score
Key exclusion criteria (5 listed)
- Having neurological and orthopedic problems that may affect walking other than stroke,
- Having a history of cardiovascular and rheumatological diseases that prevent daily activities,
- Lesion or fracture in the lower extremity,
- Lower extremity spasticity 4 according to the modified Ashworth Scale,
- Individuals with aphasia and communication 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 |
|---|---|---|
| TestMeasurements | Other | One group |
Primary outcome
Trunk Impairment Scale
Time frame: At baseline
The Trunk Impairment Scale consists of 3 subscales: static sitting balance (3 items), dynamic sitting balance (10 items) and coordination (4 items). The maximum score of the owner is 7, 10 and 6 points respectively. The Total Trunk Impairment Scale score ranges from 0 to 23, with higher scores indicating better trunk control.
Tinetti Balance and Gait Test
Time frame: At baseline
It consists of two parts, walking and balance. Consisting of 16 questions in total, the scale consists of 9 questions in which balance is evaluated first, followed by 7 questions in which gait is evaluated. The total score obtained by the evaluated participant from the first 9 questions constitutes the balance score, and the total score obtained from the following 7 questions constitutes the walking score. 2 points means that the requested task was done correctly, 1 point means that the task was done with adaptations, and 0 points means that the desired task could not be done. A total test score of 18 or less indicates a high fall risk, a moderate fall risk of 19-24 points, and a low-level fall risk with a score above 24.
Ten Meter Walking Test
Time frame: At baseline
During the test, the patient walks at a normal walking pace for a distance of 10 meters and the time is recorded.
Fugl Mayer Assesment of Sensorimotor Function
Time frame: At baseline
The sensory subscale of FMA (FMA-S) consists of 12 sub-parameters; 4 items are for light touch and 8 items are for proprioception sense. Scoring is between 0-24 points. The light touch sensation is subjectively tested. Joint position is tested on the thumb, wrist, elbow, and interphalangeal joint of the glenohumeral joint. Position sense of the lower extremities is tested on the toe, ankle, knee and hip joint.
1 secondary outcome
Turkish version of Postural Assessment Scale for Stroke Patients (PASS-T)
Time frame: At baseline
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 17 Feb 2022.
- Individual participant dataSharing planned: Undecided
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.
Zekiye İpek Katırcı Kırmacı principal investigator
Kahramanmaras Sutcu 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 4 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 17 Feb 2022. 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: 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 17 Feb 2022.