StrokeNCT06043128
Proprioceptive Awareness in Stroke Patients With Different Trunk Impact Levels
An observational study of Stroke, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Trunk control is important for maintaining an upright posture, increasing the quality of movement during dynamic activities, and performing transfer activities safely. Individuals with stroke, which is one of the most common neurological diseases in the world, may have various degrees of trunk affect because the… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Patients With Stroke With Different Trunk Impact Levels
- How many people
- 98 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 15 Aug 2024
- How long will I take part?
- 1 Day
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will consist of stroke patients who live in Kocaeli province and exhibit a hemiplegic-hemiparetic picture for at least 6 months after the stroke event.
Who may be able to join
- Volunteering to participate in the study
- Being between the ages of 35-65
- Being diagnosed with stroke
- Having a stroke for the first time
- Mini Mental Test (MMT) Score ≥ 24
- Brunnstorm lower extremity stage ≥ 4
- Being clinically stable
Who cannot join
- Mini Mental Score <24 points
- Having cervical pain of 5 or higher on the visual analog scale
- Having serious vestibular, auditory and visual problems that affect balance (vertigo, etc.)
- Having a history of orthopedic surgery for the trunk and lower extremities
- Presence of an additional neurological disease (MS, Parkinson, Alzheimer's)
- Having joint rigidity that will prevent proprioceptive evaluation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Güler Ertuğrul
Kocaeli
GÜLER ERTUĞRUL, +90 531 950 05 90, gertugrul004@gmail.com
About this study
Official title: The Relatıonshıp Of Proprıoceptıve Awareness Wıth Balance And Spastıcıty In Patıents Wıth Stroke Wıth Dıfferent Trunk Impact Levels
Trunk control is important for maintaining an upright posture, increasing the quality of movement during dynamic activities, and performing transfer activities safely. Individuals with stroke, which is one of the most common neurological diseases in the world, may have various degrees of trunk affect because the contraction strength of the trunk muscles and their ability to work in harmony with each other are reduced. Depending on the increase in the level of trunk involvement, proprioceptive deterioration, increase in balance problems and deterioration in spasticity characteristics can be observed in patients. However, the relationship between these disorders in individuals with stroke, independent of trunk involvement, has not been defined. Therefore, in this study, we aimed to examine the relationship between proprioceptive awareness and balance and spasticity in stroke patients with different trunk involvement levels. 98 chronic stroke patients will be included in the study. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. After recording the sociodemographic and clinical characteristics of the participants, the cognitive status of the patients will be evaluated with a mini mental test. Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score obtained from the GBS. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist who performs other tests. All data obtained will be noted on a prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.
Read the detailed description
According to the inclusion and exclusion criteria, 98 chronic stroke patients will be included in the study. Written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria for the study. After the sociodemographic and clinical characteristics of the participants are recorded, the cognitive status of the patients will be evaluated with a mini mental test. The Trunk Disability Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score they receive from the GBÖ. Scores close to 23 points on the GBS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. The spasticity of the participants will be evaluated with the Modified Tardiue Scale (MTS), the spasticity of the muscles, and the proprioceptive awareness of the cervical region with the cervical joint error test. Lower extremity proprioceptive awareness will be evaluated with proprioception testing on the Technobody Prokin 252 Isokinetic Balance Platform, and balance skills will be evaluated with dynamic and static balance tests on the Tecnobody Prokin 252 Isonkinetic Balance Platform. The patients' quality of life will be evaluated with a stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist performing other tests. All data obtained will be noted on the prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.
- Conditions
- Stroke
- Being tested
- Patients With Stroke With Different Trunk Impact Levels
- Keywords
- Stroke, Balance, Proprioception, Spasticity
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients With Stroke With Different Trunk Impact LevelsOther
Also called Group with Low Body Control, Group with High Body Control
Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria.Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. Scores close to 23 points on the TIS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. All data obtained will be noted on a prepared evaluation form.
| Study group | Role | What they receive |
|---|---|---|
| Group with High Body Control | This group consists of stroke patients who received 23 or close to 23 points on the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined. Receives: Other: Patients With Stroke With Different Trunk Impact Levels | |
| Group with Low Body Control | This group consists of stroke patients who received 0 points or close to 0 points from the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined. Receives: Other: Patients With Stroke With Different Trunk Impact Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk impairment scale
It consists of 3 items with different scoring alternatives. The dynamic sitting balance subscale consists of 10 items with 0 and 1 scoring options. The coordination subscale includes 4 items with different scoring alternatives. Possible compensatory strategies used during the administration of Trunk impairment scale to the patient are also evaluated. After all items have been evaluated 3 times, the best result is recorded as the patient's performance value. A score of 23 from the scale indicates that optimal trunk control is achieved, while a score approaching 0 indicates that trunk control has decreased. Turkish validity and reliability study of Trunk impairment scale in stroke patients Sag et al. Made by.
Measured: 20 minutes
Modified Tardieu Scale
Modified Tardieu Scale consists of parameters that evaluate the angle and degree of spasticity. The scale evaluates spasticity at three different speeds in order to evaluate the speed-dependent effect of spasticity. These velocities are defined as V1, V2 and V3 velocities. V1 speed represents the evaluation at the lowest speed and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively within the full range of motion, and the value range at which spasticity is observed is calculated by the goniometer. Spasticity degree is made between 0-4. "0" indicates no spasticity, "4" indicates indefatigable clonus (>10 seconds while mainta)
Measured: 25 minutes
Evaluation of Proprioceptive Awareness
Cervical Joint Position Error Test will be applied to evaluate the awareness of the sense that detects neck position. Patients are seated in a chair with back support, 90 cm away from the target board fixed to the wall. Patients are first asked to memorize the position without their head tilting in any direction and try to find the same point after an active head movement. Active head movements include flexion, extension, and right and left rotations. The desired movements are repeated 10 times. After the movement, the horizontal, vertical and global distances of each point returned to the starting point will be recorded. To calculate the test result, the average values of the incorrect distances in centimeters will be calculated.
Measured: 30 minutes
Evaluation of static and dynamic balance
To measure balance performance, patients are given a movable balance platform on the Tecnobody Prokin 252 balance platform, powered by air piston servo motors. The patient is raised on the platform that detects the sensitive measurement, which can be both movable and fixed. Thanks to the automatic engine locking function, the system instantly switches from dynamic to static measurement and provides measurement of two different balances with objective results.
Measured: 15 minutes
Stroke-Specific Quality of Life Scale
It consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work efficiency, and a total of 49 items. In PESS, increasing the total score indicates that the quality of life increases, while decreasing the total score indicates that the quality of life decreases.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion27 Feb 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güler ERTUĞRUL, Suleyman Demirel University
- Investigators
- GÜLER ERTUĞRUL, Principal investigator, Süleyman Demirel University Faculty of Health SciencesMEHMET DURAY, Study director, Süleyman Demirel University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043128
- Sponsor's protocol ID
- 573
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relatıonshıp Of Proprıoceptıve Awareness Wıth Balance And Spastıcıty In Patıents Wıth Stroke Wıth Dıfferent Trunk Impact Levels
- ClinicalTrials.gov ID
- NCT06043128
- Acronym / sponsor ID
- 573
- Conditions
- Stroke
- Keywords
- Stroke, Balance, Proprioception, Spasticity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 27 Feb 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 21 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.
Trunk control is important for maintaining an upright posture, increasing the quality of movement during dynamic activities, and performing transfer activities safely. Individuals with stroke, which is one of the most common neurological diseases in the world, may have various degrees of trunk affect because the contraction strength of the trunk muscles and their ability to work in harmony with each other are reduced. Depending on the increase in the level of trunk involvement, proprioceptive deterioration, increase in balance problems and deterioration in spasticity characteristics can be observed in patients. However, the relationship between these disorders in individuals with stroke, independent of trunk involvement, has not been defined. Therefore, in this study, we aimed to examine the relationship between proprioceptive awareness and balance and spasticity in stroke patients with different trunk involvement levels. 98 chronic stroke patients will be included in the study. Before the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria. After recording the sociodemographic and clinical characteristics of the participants, the cognitive status of the patients will be evaluated with a mini mental test. Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score obtained from the GBS. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist who performs other tests. All data obtained will be noted on a prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.
Detailed description
According to the inclusion and exclusion criteria, 98 chronic stroke patients will be included in the study. Written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria for the study. After the sociodemographic and clinical characteristics of the participants are recorded, the cognitive status of the patients will be evaluated with a mini mental test. The Trunk Disability Scale (TRS) will be used to measure trunk control, which is our independent variable. GBS will be administered by another physiotherapist who is blinded to the study. Participants will be divided into two groups, high and low trunk control, according to the score they receive from the GBÖ. Scores close to 23 points on the GBS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. The spasticity of the participants will be evaluated with the Modified Tardiue Scale (MTS), the spasticity of the muscles, and the proprioceptive awareness of the cervical region with the cervical joint error test. Lower extremity proprioceptive awareness will be evaluated with proprioception testing on the Technobody Prokin 252 Isokinetic Balance Platform, and balance skills will be evaluated with dynamic and static balance tests on the Tecnobody Prokin 252 Isonkinetic Balance Platform. The patients' quality of life will be evaluated with a stroke-specific quality of life scale. In order to prevent bias, scores obtained from the GBÖ will not be shared with the physiotherapist performing other tests. All data obtained will be noted on the prepared evaluation form. After all data is collected, intra-group and inter-group comparisons will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with High Body Control | – | Other: Patients With Stroke With Different Trunk Impact LevelsThis group consists of stroke patients who received 23 or close to 23 points on the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined. |
| Group with Low Body Control | – | Other: Patients With Stroke With Different Trunk Impact LevelsThis group consists of stroke patients who received 0 points or close to 0 points from the trunk impairment scale. In these patients, muscle stiffness, awareness of the sense of balance and position, quality of life will be evaluated and their relationships will be examined. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will consist of stroke patients who live in Kocaeli province and exhibit a hemiplegic-hemiparetic picture for at least 6 months after the stroke event.
Key inclusion criteria (7 listed)
- Volunteering to participate in the study
- Being between the ages of 35-65
- Being diagnosed with stroke
- Having a stroke for the first time
- Mini Mental Test (MMT) Score ≥ 24
Key exclusion criteria (6 listed)
- Mini Mental Score <24 points
- Having cervical pain of 5 or higher on the visual analog scale
- Having serious vestibular, auditory and visual problems that affect balance (vertigo, etc.)
- Having a history of orthopedic surgery for the trunk and lower extremities
- Presence of an additional neurological disease (MS, Parkinson, Alzheimer's)
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 |
|---|---|---|
| Patients With Stroke With Different Trunk Impact LevelsAlso: Group with Low Body Control, Group with High Body ControlBefore the study, written and verbal "Informed Consent Form" will be obtained from all participants who meet the inclusion criteria.Trunk Impairment Scale (TRS) will be used to measure trunk control, which is our independent variable. Scores close to 23 points on the TIS will constitute the group with high trunk control, and those with scores close to 0 will constitute the group with low trunk control. Spasticity of the participants, Modified Tardiue Scale (MTS), cervical proprioceptive awareness cervical joint error test, lower extremity proprioceptive awareness Proprioception test in Technobody Prokin 252 Isokinetic Balance Platform, balance skills Dynamic and static balance in Tecnobody Prokin 252 Isonkinetic Balance Platform will be evaluated by tests. The patients' quality of life will be evaluated with the stroke-specific quality of life scale. All data obtained will be noted on a prepared evaluation form. | Other | Group with High Body Control, Group with Low Body Control |
Primary outcome
Trunk impairment scale
Time frame: 20 minutes
It consists of 3 items with different scoring alternatives. The dynamic sitting balance subscale consists of 10 items with 0 and 1 scoring options. The coordination subscale includes 4 items with different scoring alternatives. Possible compensatory strategies used during the administration of Trunk impairment scale to the patient are also evaluated. After all items have been evaluated 3 times, the best result is recorded as the patient's performance value. A score of 23 from the scale indicates that optimal trunk control is achieved, while a score approaching 0 indicates that trunk control has decreased. Turkish validity and reliability study of Trunk impairment scale in stroke patients Sag et al. Made by.
Modified Tardieu Scale
Time frame: 25 minutes
Modified Tardieu Scale consists of parameters that evaluate the angle and degree of spasticity. The scale evaluates spasticity at three different speeds in order to evaluate the speed-dependent effect of spasticity. These velocities are defined as V1, V2 and V3 velocities. V1 speed represents the evaluation at the lowest speed and V3 represents the evaluation at the highest speed. In all 3 speeds, the target joints are moved passively within the full range of motion, and the value range at which spasticity is observed is calculated by the goniometer. Spasticity degree is made between 0-4. "0" indicates no spasticity, "4" indicates indefatigable clonus (>10 seconds while mainta)
Evaluation of Proprioceptive Awareness
Time frame: 30 minutes
Cervical Joint Position Error Test will be applied to evaluate the awareness of the sense that detects neck position. Patients are seated in a chair with back support, 90 cm away from the target board fixed to the wall. Patients are first asked to memorize the position without their head tilting in any direction and try to find the same point after an active head movement. Active head movements include flexion, extension, and right and left rotations. The desired movements are repeated 10 times. After the movement, the horizontal, vertical and global distances of each point returned to the starting point will be recorded. To calculate the test result, the average values of the incorrect distances in centimeters will be calculated.
Evaluation of static and dynamic balance
Time frame: 15 minutes
To measure balance performance, patients are given a movable balance platform on the Tecnobody Prokin 252 balance platform, powered by air piston servo motors. The patient is raised on the platform that detects the sensitive measurement, which can be both movable and fixed. Thanks to the automatic engine locking function, the system instantly switches from dynamic to static measurement and provides measurement of two different balances with objective results.
Stroke-Specific Quality of Life Scale
Time frame: 10 minutes
It consists of 12 subsections, including energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work efficiency, and a total of 49 items. In PESS, increasing the total score indicates that the quality of life increases, while decreasing the total score indicates that the quality of life decreases.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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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.
GÜLER ERTUĞRUL principal investigator
Süleyman Demirel University Faculty of Health Sciences
MEHMET DURAY study director
Süleyman Demirel University Faculty of Health Sciences
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 Suleyman Demirel 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 6 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: status not confirmed, as of the sponsor's last update on 22 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GÜLER ERTUĞRUL (+90 531 950 05 90, gertugrul004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk impairment scale (time frame: 20 minutes). The study lists 5 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 22 Sep 2023.