Innovative Physiotherapy in Stroke Rehabilitation

NCT07011888 | Not Yet Recruiting FDA Device

• 1 other identifier: E-10840098-202.3.02-3288
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke, Ischemic; Chronic Stroke Survivors

Keywords

chronic stroke; Saebo; ultrasound therapy; vestibular training; stroke rehabilitation; balance; case report; functional independence

Outcome Measures

Primary Outcomes (7)

• 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.

  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

Study Arms (1)

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.

Device: SaeboStim GO with Saebo Glove Rehabilitation Program

Interventions

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.

Also known as: vestibular rehabilitation therapy, therapeutic ultrasound

Single-Case Rehabilitation Intervention

Eligibility Criteria

• Age: 50 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sevval Yesilkır: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• Sevval Yesilkır, MSc

  PRINCIPAL INVESTIGATOR

• Gizem Ergezen Sahin, Dr. Assistant Professor

  Medipol University

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, MSc

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: November 15, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)