- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07834255
The Effect of Robotic Rehabilitation in Stroke Patients (Hemiplegia)
The Effect of Robot-Assisted Upper Extremity Rehabilitation on Motor Functions, Shoulder Pain, Cognitive Functions and Glenohumeral Subluxation in Patients With Early Subacute Stroke
The goal of this randomized controlled clinical trial is to investigate the efficacy and safety of adding robot-assisted upper extremity therapy to conventional rehabilitation in patients with early subacute stroke.The primary objective is to evaluate whether integrating an upper extremity exoskeleton robot (ArmeoPower) with standard conventional therapy yields superior improvements compared to conventional physiotherapy alone. The study investigates outcomes across multiple clinical domains, including upper extremity motor functions, muscle tone/spasticity, hemiplegic shoulder pain, cognitive functions, glenohumeral subluxation, and overall functional independence in daily living activities.A total of 36 eligible stroke participants are randomly allocated into two parallel groups in a 1:1 ratio:Control Group (Conventional Therapy): Participants receive 30 sessions of conventional neurorehabilitation (40 minutes per session, 5 days per week for 6 weeks).Intervention Group (Robotic Therapy): Participants receive a combined protocol consisting of 20 sessions of conventional physiotherapy and 10 sessions of robot-assisted training (20 minutes per session, 2-3 times per week), completing a total of 30 intervention sessions over a 6-week period.Detailed clinical, functional, and structural assessments are conducted for all participants at baseline (pre-intervention) and immediately following the completion of the 6-week treatment protocol (post-intervention) to analyze within-group and between-group changes.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
Background and Rationale:Upper extremity hemiparesis, shoulder pain, and glenohumeral subluxation are highly prevalent complications following a stroke, severely limiting activities of daily living and overall functional independence. The early subacute period represents a critical therapeutic window characterized by peak neuroplasticity and spontaneous recovery. Standard conventional rehabilitation involves targeted techniques like Bobath, Brunnstrom, and Proprioceptive Neuromuscular Facilitation (PNF). However, achieving the necessary movement repetition and intensity remains a clinical challenge. Integrating robot-assisted training, such as the ArmeoPower exoskeleton system, provides intensive, highly repeatable, goal-oriented, and gamified sensorimotor training with real-time feedback. While literature focuses mostly on motor outcomes, comprehensive trials combining motor, pain, cognitive, and structural shoulder subluxation evaluations in the early subacute phase are scarce. This study aims to investigate whether adding robot-assisted upper extremity therapy to conventional rehabilitation yields superior clinical outcomes compared to conventional therapy alone.
Methodology and Randomization:This is a prospective, randomized, controlled clinical trial. A total of 36 eligible individuals with early subacute stroke and concurrent shoulder pain will be enrolled and randomly allocated in a 1:1 ratio into two parallel groups: the Robotic Therapy Group (n=18) and the Conventional Therapy Group (n=18). Randomization and allocation will be performed to minimize bias. To ensure the methodological rigor and minimize evaluation bias, the statistical analysis will be performed by a blinded biostatistician who is completely unaware of the group assignments, treatment allocations, and clinical outcomes.
Study Interventions:Conventional Therapy Group (Control): Participants will receive 30 sessions of conventional neurorehabilitation (40 minutes per session, 5 days a week for 6 weeks) incorporating neurodevelopmental techniques (Bobath, PNF, Brunnstrom), range of motion, stretching, and strengthening exercises.Robotic Therapy Group (Intervention): Participants will receive a combination of 20 sessions of conventional therapy and 10 sessions of robot-assisted training using the ArmeoPower exoskeleton system (20 minutes per session, 2-3 times per week), totaling 30 intervention sessions over 6 weeks.
Assessments:Detailed clinical and functional assessments will be conducted at baseline (pre-intervention) and immediately following the 6-week treatment protocol (post-intervention). Evaluated domains include upper extremity motor function, spasticity/muscle tone, shoulder pain severity, cognitive function, structural shoulder subluxation, and functional independence.
Note on Protocol Amendment and Ethics Approval:Following the thesis defense examination, a minor amendment to the study title was requested by the thesis jury. This title amendment was officially reviewed and approved by the Ankara Bilkent City Hospital Medical Research Ethics Committee (TABED). The initial institutional ethics approval was granted under number [TABED 1/1994/2025], and the subsequent approved title amendment was issued under the new approval number [TABED 1/2862/2026] on [01/07/2026]. Due to character limitations in the system's board approval field, the most recent amendment approval number has been entered.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Çankaya
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Ankara, Çankaya, Turecko (Türkiye), 06800
- Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Stroke history between 2-4 weeks
- No prior stroke
- Age between 35-70 years
- No prior diagnosis of orthopedic upper extremity disease or orthopedic upper extremity surgery
- No prior diagnosis of neurological disease
- Cognitive status suitable for rehabilitation
- At a supported sitting level for the treatment group
- Having shoulder pain as assessed by the Brief Pain Inventory before the study
Exclusion Criteria:
- More than 1 month having passed since the stroke
- Having experienced more than one stroke
- Having a prior diagnosis of Impingement syndrome, Frozen shoulder, Rotator cuff injury
- Having a prior diagnosis of Alzheimer's, Dementia, Parkinson's disease
- Failure to provide the necessary participation in evaluation and treatment within the scope of the study
- Suffering a second stroke during the study process
- Discharge before completing the study process
- Lack of willingness to participate in the study
- Loss of voluntary participation in the study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: The Robotic Therapy Group
Participants in this group receive a combined protocol consisting of 20 sessions of conventional physiotherapy and 10 sessions of robot-assisted upper extremity training, totaling 30 sessions over a 6-week period. |
Applied via the ArmeoPower exoskeleton device for 10 sessions (20 minutes per session, 2-3 times per week). The training incorporates gamified sensorimotor exercises (High Flyer, Rain Mug, Submarine) focusing on shoulder flexion-extension, horizontal adduction-abduction, elbow flexion-extension, wrist flexion-extension, and finger movements. The gravity-compensation and robotic assistance levels are dynamically adjusted based on the patient's motor function.
Ostatní jména:
Applied for 30 sessions (40 minutes per session, 5 days per week for 6 weeks). The standard program incorporates neurodevelopmental techniques (Bobath, PNF, Brunnstrom concepts), passive/active range of motion (ROM) exercises for the upper and lower extremities, shoulder joint stretching and stabilization, targeted strengthening exercises, trunk/sitting balance training, and verticalization protocols. Each exercise is performed in sets of 10 repetitions. |
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Aktivní komparátor: The Conventional Therapy Group
Participants in this group receive 30 sessions of standard conventional neurorehabilitation over a 6-week period. |
Applied for 30 sessions (40 minutes per session, 5 days per week for 6 weeks). The standard program incorporates neurodevelopmental techniques (Bobath, PNF, Brunnstrom concepts), passive/active range of motion (ROM) exercises for the upper and lower extremities, shoulder joint stretching and stabilization, targeted strengthening exercises, trunk/sitting balance training, and verticalization protocols. Each exercise is performed in sets of 10 repetitions. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fugl-Meyer Motor Assessment Scale
Časové okno: Baseline and 6 weeks
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The Fugl-Meyer Motor Assessment Scale reflects the stages of motor development. Each item in the assessment is scored out of 2 points. Each parameter is scored as follows: 0: Failure, 1: Partially successful performance, 2: Completely successful performance. The maximum achievable upper extremity motor performance score is 66 points. In upper extremity assessment, 53-66 points indicate full capacity, 48-52 points indicate sufficient capacity, 32-47 points indicate limited capacity, and 31 points and below indicate poor capacity. The Fugl-Meyer Motor Assessment Scale (FMAS) evaluates upper extremity motor function totals 66 points, with a maximum of 36 points for the upper arm, 10 points for the wrist, 14 points for the hand, and 6 points for coordination. A high score indicates good motor function. In our study, only the FMAS upper extremity motor function score was used to evaluate upper extremity motor functions. |
Baseline and 6 weeks
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Brunnstrom Motor Assessment
Časové okno: Baseline and 6 weeks
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This is a test that evaluates the motor development of hemiplegic individuals. In this test, the recovery process of a hemiplegic individual is defined in six stages. According to this staging, the lowest stage is stage I (flaccid, lack of voluntary movement), and the highest stage is stage VI (isolated joint movement). The upper extremity, lower extremity, and hand are evaluated separately. Higher Brunnstrom stages indicate better motor development. |
Baseline and 6 weeks
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Modified Ashworth Scale
Časové okno: Baseline and 6 weeks
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Muscle tone was assessed using the Modified Ashworth Scale (MAS). MAS is an updated version of the Ashworth Scale, first described by Ashworth in 1964 to measure the increase in muscle tone. This scale evaluates the resistance during passive movement of an extremity on a scale of 6 points (0, 1, 1+, 2, 3, 4) from 0 to 4. Although its validity and reliability are debated due to the lack of guidelines regarding positioning and application, MAS is widely used today in the assessment of spasticity because it does not require any tools and is easy to apply. The tone of the shoulder flexor and adductor, elbow flexor, wrist, and finger flexor muscles in the upper extremity of the individuals included in the study was assessed according to their MAS. All muscle groups were scored according to their MAS after a single, rapid, passive stretch, starting from their shortest position. |
Baseline and 6 weeks
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Brief Pain Inventory
Časové okno: Baseline and 6 weeks
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It uses numerical rating scales from 0 to 10. The BPI scale defines pain as follows: 1 - 4 = Mild Pain, 5 - 6 = Moderate Pain, 7 - 10 = Severe Pain. Since pain can vary significantly throughout the day, the BPI asks patients to rate their pain at the time they respond to the questionnaire. In addition, the questionnaire asks the participant to indicate the worst, least, and average pain in the previous week. "0 = no interference; 10 = completely interferes". The BPI evaluates pain by dividing it into 2 subheadings: pain intensity and interference of pain with daily functioning. Pain intensity is calculated by averaging the worst, least, average, and current pain scores, which are queried between items 3 and 6. Interference of pain with daily functioning is calculated by averaging 7 items that assess interference with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life. In the study, patients were questioned about shoulder pain. |
Baseline and 6 weeks
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Montreal Cognitive Assessment Test
Časové okno: Baseline and 6 weeks
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MoCA was developed as a rapid screening test for mild cognitive impairment. MoCA assesses various cognitive functions, including attention and concentration, executive functions, memory, language, visualization skills, abstract thinking, calculation, and orientation. The MoCA takes approximately 10 minutes to administer. The maximum possible total score is 30. Therefore, a score of 21 or higher is considered normal. |
Baseline and 6 weeks
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Finger Width Palpation Method
Časové okno: Baseline and 6 weeks
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This is a palpation technique used by clinicians to determine whether shoulder subluxation is actually present. The space between the acromion and the humeral head is palpated to determine how many finger widths can fit into it. The number of fingers is related to a subluxation grading system. The grading increases with the amount of subluxation. A 0-5 grading scheme is used: 0: No subluxation
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Baseline and 6 weeks
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Functional Independence Measure (FIM)
Časové okno: Baseline and 6 weeks
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This scale helps identify and classify cognitive and motor disabilities, and determines independence in daily life. It is a measure that assesses a person's performance in daily living activities. It consists of two sections: motor function and cognitive function. Items are scored from 1 to 7 (1 = full assistance, 7 = full independence). The total score ranges from 18 to 126. A score of 18 indicates complete dependence, while a score of 126 indicates complete independence. |
Baseline and 6 weeks
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Demographic Information Form
Časové okno: Baseline
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Through a demographic information form, participants' gender, age, height, body weight, body mass index, education level, employment status, occupation, marital status, number of children, dominant hand, smoking and alcohol use, contact information, chronic diseases, medication use, psychological disorders, and stroke-related information such as date of stroke, date of hospitalization, side of the body affected by the stroke, type of stroke, and assistive devices used were recorded. |
Baseline
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Azize R Tunc, Assist Prof, Lokman Hekim University
- Ředitel studie: Burcu Yanık, Professor, Ankara City Hospital Bilkent
- Vrchní vyšetřovatel: HALE ÖZDEMİR, PT, MSc, Ankara City Hospital Bilkent
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Bolest
- Neurologické projevy
- Nemoci pohybového aparátu
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Cévní onemocnění
- Kardiovaskulární choroby
- Onemocnění kloubů
- Artralgie
- Ochrnutí
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Cévní mozková příhoda
- Hemoragická mrtvice
- Mrtvice
- Bolest ramene
- Hemiplegie
Další identifikační čísla studie
- TABED 1/ 2862/2026
- Corresponding Author (Identifikátor registru: AZİZE REDA TUNÇ)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data that underlie the results reported in this article, after de-identification (specifically restricted to data supporting the text, tables, and figures), will be made available to researchers who provide a methodologically sound proposal.
Časový rámec sdílení IPD
Beginning 6 months and ending 36 months following article publication.
Kritéria přístupu pro sdílení IPD
Types of analyses: To achieve aims in the approved proposal. Proposals should be directed to hhalezdmr1@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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