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| ID | Type | Description | Link |
|---|---|---|---|
| E-10840098-202.3.02-3288 | Registry Identifier | Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SaeboStim GO with Saebo Glove Rehabilitation Program | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sevval Yesilkır, MSc | Contact | +90 530 869 64 76 | sevvalyslkr98@gmail.com | |
| Gizem Ergezen Sahin, Dr. Assistant Professor | Contact | +90 216 681 24 70 | gergezen@medipol.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Sevval Yesilkır, MSc | Principal Investigator | |
| Gizem Ergezen Sahin, Dr. Assistant Professor | Medipol University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medipol University | Istanbul | Beykoz | 34815 | Turkey (Türkiye) |
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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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| ID | Term |
|---|---|
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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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.
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| 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. | 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. | 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. | 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. | The beginning of study and after 6 weeks |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |