An interventional study of Robot-Assisted Upper Extremity Therapy and Conventional Physiotherapy in Subacute Stroke, Stroke and Ischemic Stroke, sponsored by Lokman Hekim University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Lokman Hekim University · Not applicable, Interventional, and Treatment
Among 484 studies in Stroke with a site in Turkey — 95 open to participants now, 107 under way, 3 of them phase 3. Stroke · Turkey.
Among the 484 studies in Stroke with a site in Turkey, this one is the 185th largest by enrollment of the 320 interventional ones that give a count, is one of 61 that started in 2026, is one of 291 with no phase, and was the 474th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →95 of the 484 studies in Stroke with a site in Turkey are open now. Recruiting first, the newest first:
Izmir City Hospital · Sites in Turkey
Ages 18–90
Izmir City Hospital · Sites in Turkey
Ages 18–90
Istanbul University - Cerrahpasa · Sites in Turkey
Ages 18–75
Bitlis Eren University · Sites in Turkey
Ages 18–75
Istinye University · Sites in Turkey
Ages 40–70
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 35 Years to 70 Years · all sexes · no healthy volunteers.
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484 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 61 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 36 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Median enrollment 40 across the 320 interventional studies, 63 across the 164 observational. Of the 338 that completed or were terminated, 22 (7%) have results posted.
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29 of 484 have an industry lead sponsor. The 10 most frequent:
Lokman Hekim University is the lead sponsor of 43 studies on the registry; 17 are open to participants now.
Lokman Hekim University has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
34 of the studies in Stroke with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07551141Bitlis Eren UniversityEffects of Plantar Vibration on Gait and Balance in Stroke | 2026-11 |
| NCT07550270Gaziler Physical Medicine and Rehabilitation Education and Research HospitalBody Weight-Supported and Virtual Reality Gait Training in Stroke Patients | 2026-11 |
| NCT07565363Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalThe Effect of Motor Imagery on Upper Extremity Function in Stroke Rehabilitation | 2026-11-20 |
| NCT06166862Karamanoğlu Mehmetbey UniversityAction Observation and Motor Imagery Therapy in Stroke | 2026-12 |
| NCT07822854Nermin KARTVagal Stimulation in Individuals With Stroke | 2026-12-01 |
Add all 34 to your calendar (.ics) → With an account.
Among the 484 studies in Stroke with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Exclusion Criteria:
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.
Device: Robot-Assisted Upper Extremity Therapy · Other: Conventional Physiotherapy
Participants in this group receive 30 sessions of standard conventional neurorehabilitation over a 6-week period.
Other: Conventional Physiotherapy
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.
Also known as: Armeopower upper extremity robotic device
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.
Fugl-Meyer Motor Assessment Scale
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.
Time frame: Baseline and 6 weeks
Brunnstrom Motor Assessment
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.
Time frame: Baseline and 6 weeks
Modified Ashworth Scale
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.
Time frame: Baseline and 6 weeks
Brief Pain Inventory
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.
Time frame: Baseline and 6 weeks
Montreal Cognitive Assessment Test
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.
Time frame: Baseline and 6 weeks
Finger Width Palpation Method
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 1. ½ finger width space 2. 1 finger width space 3. 1½ finger width space 4. 2 finger width space 5. 2½ finger width space
Time frame: Baseline and 6 weeks
Functional Independence Measure (FIM)
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.
Time frame: Baseline and 6 weeks
Demographic Information Form
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.
Time frame: Baseline
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 6 months and ending 36 months following article publication.
Access criteria: 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.
Ran from Jan 2026 to primary completion in Mar 2026, 2 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 2 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Lokman Hekim University