Innovative Physiotherapy in Stroke Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-50
SponsorSevval Yesilkır
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
SaeboStim GO with Saebo Glove Rehabilitation Program
DeviceThe 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.
Treatment groups
1 Participants
are divided into 1 treatment groupGroup A: Single-Case Rehabilitation InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
The beginning of study and after 6 weeks2
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.
Time frame
The beginning of study and after 6 weeks3
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.
Time frame
The beginning of study and after 6 weeks4
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.
Time frame
The beginning of study and after 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Sevval Yesilkır
Lead sponsor
Medipol University
Sponsor institution
Source ClinicalTrials.gov
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