Stroke, IschemicNCT07011888
Innovative Physiotherapy in Stroke Rehabilitation
A study testing SaeboStim GO with Saebo Glove Rehabilitation Program in people with Stroke, Ischemic and Chronic Stroke Survivors, run by Sevval Yesilkır at 1 site in Turkey (Türkiye).
Trial summary
This study reports a single-case rehabilitation program for a chronic stroke patient focusing on innovative physiotherapy techniques. Over six weeks, the patient will undergo combined treatments including vestibular rehabilitation therapy, ultrasound therapy, and functional hand therapy using Saebo devices. Read more about this study
- Who is it for?
- Ages 50 to 50 years, men only
- Conditions the study is for
- Stroke, Ischemic, Chronic Stroke Survivors
- What is being tested?
- SaeboStim GO with Saebo Glove Rehabilitation Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 years and older.
- Diagnosis of chronic ischemic stroke (more than 6 months post-stroke).
- Presence of motor dysfunction, balance impairment, or gait difficulties related to stroke.
- Willingness and ability to participate in a comprehensive rehabilitation program involving physical therapy and device-assisted interventions (e.g., SaeboStim GO, Saebo Glove).
Who cannot join
- Presence of uncontrolled systemic diseases or active infections that would interfere with rehabilitation.
- Severe psychiatric disorders that would impede participation.
- Contraindications to the use of physical therapy devices or interventions used in the study.
- Severe orthopedic conditions that preclude participation in the rehabilitation program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
Gizem Ergzen Sahin, Dr. Assistant Professor, +90 216 681 24 70, gergezen@medipol.edu.tr
About this study
Official title: Current and Innovative Physiotherapy Practices in Stroke Rehabilitation: A Clinical Case Report
This study reports a single-case rehabilitation program for a chronic stroke patient focusing on innovative physiotherapy techniques. Over six weeks, the patient will undergo combined treatments including vestibular rehabilitation therapy, ultrasound therapy, and functional hand therapy using Saebo devices. The goal is to improve motor functions and daily living independence. This report aims to share clinical insights and outcomes to support stroke rehabilitation practices.
Read the detailed description
This single-case clinical report presents a comprehensive rehabilitation program for a stroke patient over a period of six weeks. The intervention consists of three main components:
- Vestibular Rehabilitation Therapy (VRT): Exercises aimed at improving ocular motor control, balance, and vestibulo-ocular reflex through specific eye movements and walking patterns, progressing in difficulty over time.
- Ultrasound Therapy: Application of low-frequency portable ultrasound to targeted muscle groups to reduce spasticity and promote muscle relaxation, performed in prone or side-lying positions.
- Functional Hand Rehabilitation: Use of SaeboStim GO and Saebo Glove devices to reduce spasticity in upper limb muscles and enhance hand function through electrical stimulation and active-assisted exercises.
Throughout the program, treatment sessions are conducted three times weekly, each lasting two hours. Outcomes related to motor improvement, spasticity reduction, and functional independence are monitored and evaluated using descriptive statistics and time-series analysis.
The purpose of this report is to provide detailed clinical insights into the application of combined innovative physiotherapy methods in stroke rehabilitation and to highlight their potential benefits.
- Conditions
- Stroke, Ischemic, Chronic Stroke Survivors
- Being tested
- SaeboStim GO with Saebo Glove Rehabilitation Program
- Keywords
- chronic stroke, Saebo, ultrasound therapy, vestibular training, stroke rehabilitation, balance, case report, functional independence
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboStim GO with Saebo Glove Rehabilitation ProgramDevice
Also called vestibular rehabilitation therapy, therapeutic ultrasound
The intervention consists of a comprehensive rehabilitation program for a chronic stroke patient, utilizing the SaeboStim GO device combined with the Saebo Glove orthosis to facilitate and strengthen hand and upper limb motor function. The program also includes therapeutic ultrasound to support tissue healing, and vestibular rehabilitation therapy (VRT) to enhance motor learning and engagement. This combined approach aims to improve motor skills, balance, gait, daily living activities, and cognitive functions over a treatment period of six months.
| Study group | Role | What they receive |
|---|---|---|
| Single-Case Rehabilitation Intervention | Experimental | This arm involves a rehabilitation program for a chronic stroke patient including VRT (Vestibular Rehabilitation Therapy), therapeutic ultrasound, and use of SaeboStim GO device combined with Saebo Glove orthosis to improve motor skills, balance, gait, activities of daily living, and cognitive functions. Receives: Device: SaeboStim GO with Saebo Glove Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index
The Barthel Index (BI) is a widely used functional assessment tool developed to assess an individual's level of independence in activities of daily living. It assesses ten basic categories, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (bed to chair), mobility on flat surfaces, and stair climbing. Each category is scored based on the level of assistance the individual requires; the total scores ranges from 0 to 100, with higher scores indicating greater functional independence. Score between 0-20 indicate severe dependency, 21-60 moderate dependency, 61-90 mild dependency, 91-99 near-complete independence, 100 complete independence. The Turkish version of the Barthel Index has been validated for clinical use.
Measured: The beginning of study and after 6 weeks
The Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) is a short, multidimensional cognitive assessment tool developed to detect mild cognitive impairments in the early stages. The test aims to measure performance in various cognitive domains such as attention and concentration, executive functions, memory, language, visual-spatial skills, abstraction, calculation, and orientation in time and space. The MoCA is scored out of a total of 30 points, and based on generally accepted thresholds, a score of 26 and above indicates normal cognitive functioning, while a score of 25 and below indicates a risk of cognitive impairment. Since educational level may affect the result, it is recommended to add one point to the final score for individuals with less than 12 years of education. A validated Turkish version of the MoCA is used in this study.
Measured: The beginning of study and after 6 weeks
Modified Falls Efficacy Scale
The Modified Falls Efficacy Scale (MFES) is a self-report-based tool that assesses the fear of falling individuals experience while performing their daily activities. The scale consists of 14 items, each scored between 0 (no confidence) to 10 (complete confidence). The highest possible total score is 140, with an average score of up to 10. Higher average scores indicate a low fear of falling during the activity, while lower scores indicate a high level of fear. The Turkish version of the MFES has been validated for use in clinical assessments.
Measured: The beginning of study and after 6 weeks
Fugl-Meyer Assessment
Fugl-Meyer Assessment (FMA) originally evaluates five components: lower extremity motor function (FMA-LE, maximum score 34) and upper extremity motor function (FMA-UE, maximum score 66), sensory function (maximum score 24), balance (maximum score 14), range of motion (maximum score 44) and joint pain (maximum score 44). Two areas will be evaluated in this study: FMA-LE and FMA-UE. FMA-LE includes six categories such as basic reflex movements in the lower extremity, voluntary movements with muscle synergies, coordination and movement speed (tremor, dysmetria, timing). Most tasks are scored between 0 and 2; 0 indicates no movement, 1 partial movement and 2 correct movement. The FMA-UE assesses nine categories for the upper extremity: primary reflexes, flexor synergy, extensor synergy, combined synergy movements, out-of-synergy movements, wrist movements, hand movements, and coordination (tremor, dysmetria, speed). Most tasks are similarly scored from 0 to 2.
Measured: The beginning of study and after 6 weeks
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a timed-based, task-oriented performance test developed to assess upper extremity motor function following stroke. This test, which consists of 15 tasks in total, allows for the monitoring of changes in motor skills over time. The first six tasks involve timed movements of joint segments, while the remaining nine tasks evaluate holistic functional movements. Each task is scored both for completion time (in seconds) and movement quality on a scale from 0 to 5 with the maximum score is 75. The WMFT provides both qualitative and quantitative data, making it a reliable tool for tracking rehabilitation progress.
Measured: The beginning of study and after 6 weeks
Berg Balance Scale
The Berg Balance Scale (BBS) is a highly clinically valid and reliable tool used to assess balance performance. It is especially preferred for older adults and individuals with neurological disorders such as stroke, to determine the risk of falling due to balance issues. The scale consists of 14 tasks, each scored from 0 to 4, with a maximum total score of 56. The tasks include sitting, standing, turning, bending, and standing on one leg, covering a range of functional balance abilities. Lower scores are associated with a higher risk of falling; scores below 45 are generally considered clinically significant for fall risk.
Measured: The beginning of study and after 6 weeks
Timed Up and Go Test
The Timed Up and Go Test (TUG) is a time-based test used to measure functional mobility and fall risk by assessing how long it takes for an individual to complete a sequence of daily movements. It is frequently used to objectively assess mobility levels in older adults and patients with neurological or orthopedic conditions. During the test, the individual rises from the chair, walks three meters forward, turns around, walks back to the starting point, and sits down again. This process is timed in seconds using a stopwatch. Times under 10 seconds are considered normal levels of mobility; values between 11 and 14 seconds indicate mild mobility limitation; times over 15 seconds are associated with reduced functional independence and increased fall risk. Times above 20 seconds may raise concerns about the ability to live independently; and times exceeding 30 seconds indicate severe mobility impairment and a high risk of falls.
Measured: The beginning of study and after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start15 Nov 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group interventional study involving one participant who will receive a rehabilitation program including VRT, ultrasound therapy, NMES, and the use of SaeboStim GO and Saebo Glove devices. The study aims to evaluate the effects of this combined intervention on motor skills, balance, gait ability, independence in daily activities, and cognitive functions over the treatment period.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sevval Yesilkır
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevval Yesilkır, Medipol University
- Investigators
- Sevval Yesilkır, MSc, Principal investigatorGizem Ergezen Sahin, Dr. Assistant Professor, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011888
- Sponsor's protocol ID
- E-10840098-202.3.02-3288
- Other IDs
- E-10840098-202.3.02-3288
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study involves a single patient case report, and sharing individual participant data may compromise patient privacy and confidentiality. Therefore, IPD sharing is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current and Innovative Physiotherapy Practices in Stroke Rehabilitation: A Clinical Case Report
- ClinicalTrials.gov ID
- NCT07011888
- Acronym / sponsor ID
- E-10840098-202.3.02-3288
- Conditions
- Stroke, Ischemic, Chronic Stroke Survivors
- Keywords
- chronic stroke, Saebo, ultrasound therapy, vestibular training, stroke rehabilitation, balance, case report, functional independence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sevval YesilkırUniversity, hospital or other
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 10 Jun 2025 (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.
This study reports a single-case rehabilitation program for a chronic stroke patient focusing on innovative physiotherapy techniques. Over six weeks, the patient will undergo combined treatments including vestibular rehabilitation therapy, ultrasound therapy, and functional hand therapy using Saebo devices. The goal is to improve motor functions and daily living independence. This report aims to share clinical insights and outcomes to support stroke rehabilitation practices.
Detailed description
This single-case clinical report presents a comprehensive rehabilitation program for a stroke patient over a period of six weeks. The intervention consists of three main components:
- Vestibular Rehabilitation Therapy (VRT): Exercises aimed at improving ocular motor control, balance, and vestibulo-ocular reflex through specific eye movements and walking patterns, progressing in difficulty over time.
- Ultrasound Therapy: Application of low-frequency portable ultrasound to targeted muscle groups to reduce spasticity and promote muscle relaxation, performed in prone or side-lying positions.
- Functional Hand Rehabilitation: Use of SaeboStim GO and Saebo Glove devices to reduce spasticity in upper limb muscles and enhance hand function through electrical stimulation and active-assisted exercises.
Throughout the program, treatment sessions are conducted three times weekly, each lasting two hours. Outcomes related to motor improvement, spasticity reduction, and functional independence are monitored and evaluated using descriptive statistics and time-series analysis.
The purpose of this report is to provide detailed clinical insights into the application of combined innovative physiotherapy methods in stroke rehabilitation and to highlight their potential benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group interventional study involving one participant who will receive a rehabilitation program including VRT, ultrasound therapy, NMES, and the use of SaeboStim GO and Saebo Glove devices. The study aims to evaluate the effects of this combined intervention on motor skills, balance, gait ability, independence in daily activities, and cognitive functions over the treatment period.
| Arm | Type | Receives |
|---|---|---|
| Single-Case Rehabilitation Intervention | Experimental | Device: SaeboStim GO with Saebo Glove Rehabilitation ProgramThis arm involves a rehabilitation program for a chronic stroke patient including VRT (Vestibular Rehabilitation Therapy), therapeutic ultrasound, and use of SaeboStim GO device combined with Saebo Glove orthosis to improve motor skills, balance, gait, activities of daily living, and cognitive functions. |
Who may qualify
- Ages
- 50 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 years and older.
- Diagnosis of chronic ischemic stroke (more than 6 months post-stroke).
- Presence of motor dysfunction, balance impairment, or gait difficulties related to stroke.
- Willingness and ability to participate in a comprehensive rehabilitation program involving physical therapy and device-assisted interventions (e.g., SaeboStim GO, Saebo Glove).
Key exclusion criteria (4 listed)
- Presence of uncontrolled systemic diseases or active infections that would interfere with rehabilitation.
- Severe psychiatric disorders that would impede participation.
- Contraindications to the use of physical therapy devices or interventions used in the study.
- Severe orthopedic conditions that preclude participation in the rehabilitation program.
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 |
|---|---|---|
| SaeboStim GO with Saebo Glove Rehabilitation ProgramAlso: vestibular rehabilitation therapy, therapeutic ultrasoundThe intervention consists of a comprehensive rehabilitation program for a chronic stroke patient, utilizing the SaeboStim GO device combined with the Saebo Glove orthosis to facilitate and strengthen hand and upper limb motor function. The program also includes therapeutic ultrasound to support tissue healing, and vestibular rehabilitation therapy (VRT) to enhance motor learning and engagement. This combined approach aims to improve motor skills, balance, gait, daily living activities, and cognitive functions over a treatment period of six months. | Device | Single-Case Rehabilitation Intervention |
Primary outcome
Barthel Index
Time frame: The beginning of study and after 6 weeks
The Barthel Index (BI) is a widely used functional assessment tool developed to assess an individual's level of independence in activities of daily living. It assesses ten basic categories, including feeding, bathing, grooming, dressing, bowel and bladder control, toilet use, transfers (bed to chair), mobility on flat surfaces, and stair climbing. Each category is scored based on the level of assistance the individual requires; the total scores ranges from 0 to 100, with higher scores indicating greater functional independence. Score between 0-20 indicate severe dependency, 21-60 moderate dependency, 61-90 mild dependency, 91-99 near-complete independence, 100 complete independence. The Turkish version of the Barthel Index has been validated for clinical use.
The Montreal Cognitive Assessment
Time frame: The beginning of study and after 6 weeks
The Montreal Cognitive Assessment (MoCA) is a short, multidimensional cognitive assessment tool developed to detect mild cognitive impairments in the early stages. The test aims to measure performance in various cognitive domains such as attention and concentration, executive functions, memory, language, visual-spatial skills, abstraction, calculation, and orientation in time and space. The MoCA is scored out of a total of 30 points, and based on generally accepted thresholds, a score of 26 and above indicates normal cognitive functioning, while a score of 25 and below indicates a risk of cognitive impairment. Since educational level may affect the result, it is recommended to add one point to the final score for individuals with less than 12 years of education. A validated Turkish version of the MoCA is used in this study.
Modified Falls Efficacy Scale
Time frame: The beginning of study and after 6 weeks
The Modified Falls Efficacy Scale (MFES) is a self-report-based tool that assesses the fear of falling individuals experience while performing their daily activities. The scale consists of 14 items, each scored between 0 (no confidence) to 10 (complete confidence). The highest possible total score is 140, with an average score of up to 10. Higher average scores indicate a low fear of falling during the activity, while lower scores indicate a high level of fear. The Turkish version of the MFES has been validated for use in clinical assessments.
Fugl-Meyer Assessment
Time frame: The beginning of study and after 6 weeks
Fugl-Meyer Assessment (FMA) originally evaluates five components: lower extremity motor function (FMA-LE, maximum score 34) and upper extremity motor function (FMA-UE, maximum score 66), sensory function (maximum score 24), balance (maximum score 14), range of motion (maximum score 44) and joint pain (maximum score 44). Two areas will be evaluated in this study: FMA-LE and FMA-UE. FMA-LE includes six categories such as basic reflex movements in the lower extremity, voluntary movements with muscle synergies, coordination and movement speed (tremor, dysmetria, timing). Most tasks are scored between 0 and 2; 0 indicates no movement, 1 partial movement and 2 correct movement. The FMA-UE assesses nine categories for the upper extremity: primary reflexes, flexor synergy, extensor synergy, combined synergy movements, out-of-synergy movements, wrist movements, hand movements, and coordination (tremor, dysmetria, speed). Most tasks are similarly scored from 0 to 2.
Wolf Motor Function Test
Time frame: The beginning of study and after 6 weeks
The Wolf Motor Function Test (WMFT) is a timed-based, task-oriented performance test developed to assess upper extremity motor function following stroke. This test, which consists of 15 tasks in total, allows for the monitoring of changes in motor skills over time. The first six tasks involve timed movements of joint segments, while the remaining nine tasks evaluate holistic functional movements. Each task is scored both for completion time (in seconds) and movement quality on a scale from 0 to 5 with the maximum score is 75. The WMFT provides both qualitative and quantitative data, making it a reliable tool for tracking rehabilitation progress.
Berg Balance Scale
Time frame: The beginning of study and after 6 weeks
The Berg Balance Scale (BBS) is a highly clinically valid and reliable tool used to assess balance performance. It is especially preferred for older adults and individuals with neurological disorders such as stroke, to determine the risk of falling due to balance issues. The scale consists of 14 tasks, each scored from 0 to 4, with a maximum total score of 56. The tasks include sitting, standing, turning, bending, and standing on one leg, covering a range of functional balance abilities. Lower scores are associated with a higher risk of falling; scores below 45 are generally considered clinically significant for fall risk.
Timed Up and Go Test
Time frame: The beginning of study and after 6 weeks
The Timed Up and Go Test (TUG) is a time-based test used to measure functional mobility and fall risk by assessing how long it takes for an individual to complete a sequence of daily movements. It is frequently used to objectively assess mobility levels in older adults and patients with neurological or orthopedic conditions. During the test, the individual rises from the chair, walks three meters forward, turns around, walks back to the starting point, and sits down again. This process is timed in seconds using a stopwatch. Times under 10 seconds are considered normal levels of mobility; values between 11 and 14 seconds indicate mild mobility limitation; times over 15 seconds are associated with reduced functional independence and increased fall risk. Times above 20 seconds may raise concerns about the ability to live independently; and times exceeding 30 seconds indicate severe mobility impairment and a high risk of falls.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. This study involves a single patient case report, and sharing individual participant data may compromise patient privacy and confidentiality. Therefore, IPD sharing is not planned.
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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.
Sevval Yesilkır, MSc principal investigator
Gizem Ergezen Sahin, Dr. Assistant Professor study chair
Medipol 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 SaeboStim GO with Saebo Glove Rehabilitation Program in people with Stroke, Ischemic and Chronic Stroke Survivors, run by Sevval Yesilkır 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 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: opening soon, as of the sponsor's last update on 1 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevval Yesilkır, MSc (+90 530 869 64 76, sevvalyslkr98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (time frame: The beginning of study and after 6 weeks). The study lists 7 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 1 Oct 2025.