Clinical trial NCT07011888: Innovative Physiotherapy in Stroke Rehabilitation
Official title: Current and Innovative Physiotherapy Practices in Stroke Rehabilitation: A Clinical Case Report
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke, Ischemic
Chronic Stroke Survivors
Keywords: chronic stroke
Saebo
ultrasound therapy
vestibular training
stroke rehabilitation
balance
case report
functional independence
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 1
Sex: MALE
Minimum age (years): 50
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Barthel Index
timeFrame: The beginning of study and after 6 weeks
measure: The Montreal Cognitive Assessment
timeFrame: The beginning of study and after 6 weeks
measure: Modified Falls Efficacy Scale
timeFrame: The beginning of study and after 6 weeks
measure: Fugl-Meyer Assessment
timeFrame: The beginning of study and after 6 weeks
measure: Wolf Motor Function Test
timeFrame: The beginning of study and after 6 weeks
measure: Berg Balance Scale
timeFrame: The beginning of study and after 6 weeks
measure: Timed Up and Go Test
timeFrame: The beginning of study and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
name: Sevval Yesilkır, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Medipol University
name: Gizem Ergezen Sahin, Dr. Assistant Professor
role: STUDY_CHAIR
References: