- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07011888
- Original Trial
Innovative Physiotherapy in Stroke Rehabilitation
Current and Innovative Physiotherapy Practices in Stroke Rehabilitation: A Clinical Case Report
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sevval Yesilkır, MSc
- Phone Number: +90 530 869 64 76
- Email: sevvalyslkr98@gmail.com
Study Contact Backup
- Name: Gizem Ergezen Sahin, Dr. Assistant Professor
- Phone Number: +90 216 681 24 70
- Email: gergezen@medipol.edu.tr
Study Locations
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-
Beykoz
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Istanbul, Beykoz, Turkey (Türkiye), 34815
- Istanbul Medipol University
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Contact:
- Gizem Ergzen Sahin, Dr. Assistant Professor
- Phone Number: +90 216 681 24 70
- Email: gergezen@medipol.edu.tr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single-Case Rehabilitation Intervention
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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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Barthel Index
Time Frame: The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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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.
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The beginning of study and after 6 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sevval Yesilkır, MSc
- Study Chair: Gizem Ergezen Sahin, Dr. Assistant Professor, Medipol University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-202.3.02-3288 (Registry Identifier: Istanbul Medipol University Non-Interventional Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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