StrokeNCT05992844
Kinesthetic Brain Exercise in Hemiplegic Individuals With Stroke
A study testing KB Exercises Program and Conventional Rehabilitation program in people with Stroke, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The success of conventional physical therapy in the rehabilitation of stroke patients is demonstrated in the light of studies. In this study, the effects of kinesthetic brain exercises, which is a new exercise approach to be applied together with conventional physiotherapy and rehabilitation, on fall risk, balance… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- KB Exercises Program and Conventional Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Sep 2023to 22 May 2024
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being in the 30-60 age range
- Being in the subacute/chronic period (6 months and above).
- Having unsupported sitting balance.
- Having the ability to ambulate with and without support
- Not having botox application for the lower extremities in the last 6 months
- Being at least 3 and above according to the Functional Ambulation Scale
- At least level 3 or higher according to Bruunstrom Lower Extremity Motor Staging.
Who cannot join
- Having a rheumatological, orthopedic or cardiopulmonary disease that prevents participation in exercises
- Having secondary diseases (MS, Parkinson's, spinal cord injuries, contractures, and post-fracture deformities, etc.)
- Having cognitive, visual, and auditory problems that prevent communication
- Having vestibular system disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Kinesthetic Brain Exercise on Fall Risk, Balance and Quality of Life in Hemiplegic Individuals With Stroke
The success of conventional physical therapy in the rehabilitation of stroke patients is demonstrated in the light of studies. In this study, the effects of kinesthetic brain exercises, which is a new exercise approach to be applied together with conventional physiotherapy and rehabilitation, on fall risk, balance, and quality of life will be investigated in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs.
Read the detailed description
Stroke is a clinically defined syndrome characterized by rapidly developing symptoms or signs of cerebral dysfunction with no apparent cause other than vascular causes. Symptoms last more than 24 hours and can lead to death. Findings after stroke; upper and lower extremity motor dysfunctions, spasticity, loss of balance and coordination, walking, swallowing, vision, and communication problems. It has been reported that the disability rate ranges from 13-66% and the disability rate varies between 12-64% due to these functional losses that occur after stroke.
In stroke patients, hemiplegic picture occurs depending on the size and location of the damage in the brain. hemiplegia: It is a paralysis that affects the upper and lower extremities of one side of the body. A decrease in muscle strength, loss of sensation and dysfunction occur on the affected side.
After stroke, the lower extremities are severely affected in hemiplegic individuals. Instability of ankle and knee joints is seen in hemiplegic lower extremities. However, due to instability, the center of gravity shifts towards the unaffected side, which causes balance and coordination disorders. Balance and coordination disorders in hemiplegic individuals cause poor performance in activities and an increased incidence of falls.
Kinesthetic brain exercises: Studies investigating the effects of movement, physical activity and exercises on learning and cognitive development have shown that increased attention span, better focus, better behavioral method, and physical activity that contributes to better learning are supported. Conceptually, brain exercises are expressed by the formula: Physical activity + Brain Activity = Better cognitive function.
Neuroplasticity is the basis of kinesthetic brain exercises. In the light of research, it has been found that the brain is in a state of re-activating the activity that cannot be done by using other ways. In rehabilitation sessions, it is aimed to reconstruct these pathways by transforming daily activities into purposeful exercises. According to Dennison, the founder of kinesthetic brain exercises, brain exercises; It is a combination of physical and mental training with a series of physical movements that activate the whole body in turn, improving the neural connections between the two cerebral hemispheres to enhance learning. Kinesthetic brain training consists of twenty-six simple movements combined with deep breathing. Most of these movements are done diagonally. These diagonal movements result in stimulation and integration of different parts of the brain, especially the corpus callosum, which enables faster and more integrated communication between the two hemispheres in the long run. It is claimed that this situation supports the formation of new neural connections between the two hemispheres of the brain. Drabben et al. In their study, they suggest that brain exercises may be considered a useful physical therapy strategy for older adults, as they can have a positive effect on brain functioning.
The aim of this study is to investigate the effects of kinesthetic brain exercises on lower extremity coordination and balance in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs.
Study Hypothesis as follows; Kinesthetic brain exercises have an effect on fall risk, balance and quality of life in hemiplegic individuals who have had a stroke.
- Conditions
- Stroke
- Being tested
- KB Exercises Program, Conventional Rehabilitation program
- Keywords
- STROKE, HEMIPLEGIA, COGNITIVE, DYSFUNCTION, EXERCISE
- Medical subject headings
- Stroke, Hemiplegia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB Exercises ProgramOther
Also called KINESTHETIC BRAIN EXERCISES
Kinesthetic Brain Exercises will carried out for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average.
Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase.
Conventional Rehabilitation programOther
Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| KB Exercises plus Conventional Rehabilitation Group | Experimental | While the participants in the study group will continue the conventional rehabilitation program described below for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average.
Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase. Receives: Other: KB Exercises Program; Other: Conventional Rehabilitation program |
| Conventional Rehabilitation Group | Other | Control Group; Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation. Receives: Other: Conventional Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Spasticity
Upper and lower extremity spasticity status will be evaluated according to the modified Ashworth scale. Spasticity score will be calculated by adding upper extremity spasticity scores of fingers, wrist, elbow and shoulder spasticity scores for upper extremity, and spasticity scores for lower extremity by adding toes, ankle, knee and hip spasticity scores. Higher scores indicate high spasticity.
Measured: Change from Baseline at 3 weeks
Brunnstrom Motor Staging
The Brunnstrom motor assessment is used to evaluate motor function of the hemiplegic side, upper-lower extremities, and hand. According to Brunnstrom, the healing process consists of 6 stages. While the 1st stage is the flaccid stage without isolated movement, the 6th stage is the isolated voluntary movement stage. Only the lower extremity section will be used in this study.
Measured: Change from Baseline at 3 weeks
Functional Ambulation Classification (FAS)
The Functional Ambulation Classification is a widely used ambulation scale that evaluates gait. It is scored between 0 and 5 according to the amount of support the patients receive during walking and consists of 6 categories in total. A score of 0 indicates fully dependent ambulation, while a score of 5 indicates completely independent ambulation.
Measured: Change from Baseline at 3 weeks
Activity-Specific Balance Confidence Scale
It is a self-report form that asks people to evaluate their balance performance during 16 activities determined in the home and outdoor environment. The scale consists of 16 different activities and each item is scored between 0-100. A score of 0 indicates no confidence, and a score of 100 indicates full confidence. The total score is obtained by summing each item score and dividing it by the number of items. A score below 50 indicates a low level, a score between 50-80 indicates a moderate level, and a score above 80 indicates a high level of physical activity.
Measured: Change from Baseline at 3 weeks
Timed Sit to Stand Test
It is a test used to evaluate lower extremity performance and fall risk in stroke patients. During the test, the patient sits on the arm support chair with her back straight and is asked to get up and sit 5 times in quick succession, with her arms crossed on her chest. The elapsed time is recorded in seconds. The patient who cannot stand up unassisted is allowed to get support from the chair and is noted as such. The test is repeated 3 times and the average time is taken. The discrimination cut-off value of this test in stroke individuals is accepted as 12 seconds. If the test takes 15 seconds or more, it is accepted as a risk of repeated falls in elderly individuals.
Measured: Change from Baseline at 3 weeks
Timed Up and Go Test
It is a clinical evaluation test used to evaluate fall risk and dynamic balance in individuals. Patients are asked to sit in an upright position on a chair with an upright back, and with the start command, they are asked to walk 3 meters and return to sit on the chair again. The elapsed time is recorded in seconds. If the patient is walking with an assistive device, he is allowed to walk with an assistive device. The test is repeated 3 times and the average time is recorded. If the test takes more than 14 seconds, it indicates an increased risk of falling in stroke patients.
Measured: Change from Baseline at 3 weeks
One Leg Standing Test
The one leg standing test is used to evaluate static balance and postural control. Patients are asked to stand on one leg. The test is finished when the patient touches the ground when he/she stands up or when he/she stands on one leg for 30 seconds. Both legs are repeated 3 times and the average elapsed time is recorded.
Measured: Change from Baseline at 3 weeks
Berg Balance Scale
Berg balance scale is used to evaluate postural control and fall risk. Berg balance scale consists of 14 items. Each item is scored from 0-4 by observing the performance of the individual. A score of 0 indicates that the patient could not do the activity, and 4 points indicate that she completed the activity independently. According to the Berg balance scale, the highest score that can be obtained is 56, and a score below 45 indicates the risk of falling. A score of 0-20 indicates balance disorder, an acceptable balance between 21-40, and a good balance of 41-56 points.
Measured: Change from Baseline at 3 weeks
Assessment of Fall Risk
This scale consists of 2 sections and 19 risk factors. Major risk factors are given 5 points and minor risk factors are given 1 point. Patients with a score of 5 or more on the scale are considered to have a high risk of falling, and patients with a score of less than 5 are considered to have a low risk of falling.
Measured: Change from Baseline at 3 weeks
Stroke-Specific Quality of Life Scale
This scale consists of 12 fields containing 49 items. These areas are; mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items), family role ( It consists of 3 items), vision (3 items), language (5 items), thinking (3 items), and personality traits (3 items). Each fields has a maximum score of 5 and higher scores indicate better quality of life.
Measured: Change from Baseline at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start4 Sep 2023
- Primary completion15 May 2024
- Study completion22 May 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.
- 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
- Model description
- RANDOMIZED CONTROLLED
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Taşpınar, Izmir Democracy University
- Investigators
- Hatice Resorlu, Assoc. Prof., Study chair, Çanakkale 18 March UniversityFerruh Taspinar, Prof. Dr., Study chair, Izmir Democracy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992844
- Sponsor's protocol ID
- STROKE-KBE-35
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2023
- Last updated
- 24 Jul 2024
- 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 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Kinesthetic Brain Exercise on Fall Risk, Balance and Quality of Life in Hemiplegic Individuals With Stroke
- ClinicalTrials.gov ID
- NCT05992844
- Acronym / sponsor ID
- STROKE-KBE-35
- Conditions
- Stroke
- Keywords
- STROKE, HEMIPLEGIA, COGNITIVE, DYSFUNCTION, EXERCISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 22 May 2024 (actual)
- First posted
- 15 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 success of conventional physical therapy in the rehabilitation of stroke patients is demonstrated in the light of studies. In this study, the effects of kinesthetic brain exercises, which is a new exercise approach to be applied together with conventional physiotherapy and rehabilitation, on fall risk, balance, and quality of life will be investigated in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs.
Detailed description
Stroke is a clinically defined syndrome characterized by rapidly developing symptoms or signs of cerebral dysfunction with no apparent cause other than vascular causes. Symptoms last more than 24 hours and can lead to death. Findings after stroke; upper and lower extremity motor dysfunctions, spasticity, loss of balance and coordination, walking, swallowing, vision, and communication problems. It has been reported that the disability rate ranges from 13-66% and the disability rate varies between 12-64% due to these functional losses that occur after stroke.
In stroke patients, hemiplegic picture occurs depending on the size and location of the damage in the brain. hemiplegia: It is a paralysis that affects the upper and lower extremities of one side of the body. A decrease in muscle strength, loss of sensation and dysfunction occur on the affected side.
After stroke, the lower extremities are severely affected in hemiplegic individuals. Instability of ankle and knee joints is seen in hemiplegic lower extremities. However, due to instability, the center of gravity shifts towards the unaffected side, which causes balance and coordination disorders. Balance and coordination disorders in hemiplegic individuals cause poor performance in activities and an increased incidence of falls.
Kinesthetic brain exercises: Studies investigating the effects of movement, physical activity and exercises on learning and cognitive development have shown that increased attention span, better focus, better behavioral method, and physical activity that contributes to better learning are supported. Conceptually, brain exercises are expressed by the formula: Physical activity + Brain Activity = Better cognitive function.
Neuroplasticity is the basis of kinesthetic brain exercises. In the light of research, it has been found that the brain is in a state of re-activating the activity that cannot be done by using other ways. In rehabilitation sessions, it is aimed to reconstruct these pathways by transforming daily activities into purposeful exercises. According to Dennison, the founder of kinesthetic brain exercises, brain exercises; It is a combination of physical and mental training with a series of physical movements that activate the whole body in turn, improving the neural connections between the two cerebral hemispheres to enhance learning. Kinesthetic brain training consists of twenty-six simple movements combined with deep breathing. Most of these movements are done diagonally. These diagonal movements result in stimulation and integration of different parts of the brain, especially the corpus callosum, which enables faster and more integrated communication between the two hemispheres in the long run. It is claimed that this situation supports the formation of new neural connections between the two hemispheres of the brain. Drabben et al. In their study, they suggest that brain exercises may be considered a useful physical therapy strategy for older adults, as they can have a positive effect on brain functioning.
The aim of this study is to investigate the effects of kinesthetic brain exercises on lower extremity coordination and balance in hemiplegic individuals who have had a stroke. Thus, it is thought that the effectiveness of kinesthetic brain exercises applied together with conventional physiotherapy and rehabilitation will contribute to the literature for the creation of rehabilitation programs.
Study Hypothesis as follows; Kinesthetic brain exercises have an effect on fall risk, balance and quality of life in hemiplegic individuals who have had a stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- RANDOMIZED CONTROLLED
| Arm | Type | Receives |
|---|---|---|
| KB Exercises plus Conventional Rehabilitation Group | Experimental | Other: KB Exercises Program, Other: Conventional Rehabilitation programWhile the participants in the study group will continue the conventional rehabilitation program described below for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average. Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase. |
| Conventional Rehabilitation Group | Other | Other: Conventional Rehabilitation programControl Group; Conventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being in the 30-60 age range
- Being in the subacute/chronic period (6 months and above).
- Having unsupported sitting balance.
- Having the ability to ambulate with and without support
- Not having botox application for the lower extremities in the last 6 months
Key exclusion criteria (4 listed)
- Having a rheumatological, orthopedic or cardiopulmonary disease that prevents participation in exercises
- Having secondary diseases (MS, Parkinson's, spinal cord injuries, contractures, and post-fracture deformities, etc.)
- Having cognitive, visual, and auditory problems that prevent communication
- Having vestibular system 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 |
|---|---|---|
| KB Exercises ProgramAlso: KINESTHETIC BRAIN EXERCISESKinesthetic Brain Exercises will carried out for 3 weeks, lasting 45 minutes on average, 5 sessions a week, they will participate in a total of 9 sessions of kinesthetic brain exercises, 3 sessions a week lasting 30 minutes on average. Kinesthetic Brain Exercises Program; The kinesthetic brain exercises program basically consists of 3 phases: warm-up phase, exercise phase and cool-down phase. | Other | KB Exercises plus Conventional Rehabilitation Group |
| Conventional Rehabilitation programConventional Rehabilitation program; strengthening exercises, balance/gait training, Proprioceptive Neuromuscular Facilitation techniques, neuromuscular electrical stimulation. | Other | Conventional Rehabilitation Group, KB Exercises plus Conventional Rehabilitation Group |
Primary outcome
Evaluation of Spasticity
Time frame: Change from Baseline at 3 weeks
Upper and lower extremity spasticity status will be evaluated according to the modified Ashworth scale. Spasticity score will be calculated by adding upper extremity spasticity scores of fingers, wrist, elbow and shoulder spasticity scores for upper extremity, and spasticity scores for lower extremity by adding toes, ankle, knee and hip spasticity scores. Higher scores indicate high spasticity.
Brunnstrom Motor Staging
Time frame: Change from Baseline at 3 weeks
The Brunnstrom motor assessment is used to evaluate motor function of the hemiplegic side, upper-lower extremities, and hand. According to Brunnstrom, the healing process consists of 6 stages. While the 1st stage is the flaccid stage without isolated movement, the 6th stage is the isolated voluntary movement stage. Only the lower extremity section will be used in this study.
Functional Ambulation Classification (FAS)
Time frame: Change from Baseline at 3 weeks
The Functional Ambulation Classification is a widely used ambulation scale that evaluates gait. It is scored between 0 and 5 according to the amount of support the patients receive during walking and consists of 6 categories in total. A score of 0 indicates fully dependent ambulation, while a score of 5 indicates completely independent ambulation.
Activity-Specific Balance Confidence Scale
Time frame: Change from Baseline at 3 weeks
It is a self-report form that asks people to evaluate their balance performance during 16 activities determined in the home and outdoor environment. The scale consists of 16 different activities and each item is scored between 0-100. A score of 0 indicates no confidence, and a score of 100 indicates full confidence. The total score is obtained by summing each item score and dividing it by the number of items. A score below 50 indicates a low level, a score between 50-80 indicates a moderate level, and a score above 80 indicates a high level of physical activity.
Timed Sit to Stand Test
Time frame: Change from Baseline at 3 weeks
It is a test used to evaluate lower extremity performance and fall risk in stroke patients. During the test, the patient sits on the arm support chair with her back straight and is asked to get up and sit 5 times in quick succession, with her arms crossed on her chest. The elapsed time is recorded in seconds. The patient who cannot stand up unassisted is allowed to get support from the chair and is noted as such. The test is repeated 3 times and the average time is taken. The discrimination cut-off value of this test in stroke individuals is accepted as 12 seconds. If the test takes 15 seconds or more, it is accepted as a risk of repeated falls in elderly individuals.
Timed Up and Go Test
Time frame: Change from Baseline at 3 weeks
It is a clinical evaluation test used to evaluate fall risk and dynamic balance in individuals. Patients are asked to sit in an upright position on a chair with an upright back, and with the start command, they are asked to walk 3 meters and return to sit on the chair again. The elapsed time is recorded in seconds. If the patient is walking with an assistive device, he is allowed to walk with an assistive device. The test is repeated 3 times and the average time is recorded. If the test takes more than 14 seconds, it indicates an increased risk of falling in stroke patients.
One Leg Standing Test
Time frame: Change from Baseline at 3 weeks
The one leg standing test is used to evaluate static balance and postural control. Patients are asked to stand on one leg. The test is finished when the patient touches the ground when he/she stands up or when he/she stands on one leg for 30 seconds. Both legs are repeated 3 times and the average elapsed time is recorded.
Berg Balance Scale
Time frame: Change from Baseline at 3 weeks
Berg balance scale is used to evaluate postural control and fall risk. Berg balance scale consists of 14 items. Each item is scored from 0-4 by observing the performance of the individual. A score of 0 indicates that the patient could not do the activity, and 4 points indicate that she completed the activity independently. According to the Berg balance scale, the highest score that can be obtained is 56, and a score below 45 indicates the risk of falling. A score of 0-20 indicates balance disorder, an acceptable balance between 21-40, and a good balance of 41-56 points.
Assessment of Fall Risk
Time frame: Change from Baseline at 3 weeks
This scale consists of 2 sections and 19 risk factors. Major risk factors are given 5 points and minor risk factors are given 1 point. Patients with a score of 5 or more on the scale are considered to have a high risk of falling, and patients with a score of less than 5 are considered to have a low risk of falling.
Stroke-Specific Quality of Life Scale
Time frame: Change from Baseline at 3 weeks
This scale consists of 12 fields containing 49 items. These areas are; mobility (6 items), energy (3 items), upper extremity function (5 items), work/production (3 items), temperament (5 items), self-care (5 items), social role (5 items), family role ( It consists of 3 items), vision (3 items), language (5 items), thinking (3 items), and personality traits (3 items). Each fields has a maximum score of 5 and higher scores indicate better quality of life.
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 24 Jul 2024.
- 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.
Hatice Resorlu, Assoc. Prof. study chair
Çanakkale 18 March University
Ferruh Taspinar, Prof. Dr. study chair
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KB Exercises Program and Conventional Rehabilitation program in people with Stroke, run by Izmir Democracy 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 4 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 24 Jul 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?
Evaluation of Spasticity (time frame: Change from Baseline at 3 weeks). The study lists 10 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 24 Jul 2024.