Subacute StrokeHemiplegiaNCT07834255
The Effect of Robotic Rehabilitation in Stroke Patients
A study testing Robot-Assisted Upper Extremity Therapy and Conventional Physiotherapy in people with Subacute Stroke and Stroke, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Subacute Stroke, Stroke, Ischemic Stroke
- What is being tested?
- Robot-Assisted Upper Extremity Therapy and Conventional Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2026to 4 May 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Discharge before completing the study process
- Lack of willingness to participate in the study
- Loss of voluntary participation in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital
Ankara, Çankaya, 06800
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Subacute Stroke, Stroke, Ischemic Stroke, Hemorrhagic Stroke
- Being tested
- Robot-Assisted Upper Extremity Therapy, Conventional Physiotherapy
- Keywords
- Hemiplegia, Shoulder Pain, Stroke Rehabilitation, Upper Extremity, Cognitive Remediation
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Hemiplegia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Upper Extremity TherapyDevice
Also called Armeopower upper extremity robotic device
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.
Conventional PhysiotherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| The Robotic Therapy Group | Experimental | 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. Receives: Device: Robot-Assisted Upper Extremity Therapy; Other: Conventional Physiotherapy |
| The Conventional Therapy Group | Active comparator | Participants in this group receive 30 sessions of standard conventional neurorehabilitation over a 6-week period. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
- ½ finger width space
- 1 finger width space
- 1½ finger width space
- 2 finger width space
- 2½ finger width space
Measured: 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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start2 Jan 2026
- Primary completion20 Mar 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, HALE ÖZDEMİR, Ankara Bilkent Sehir Hastanesi
- Investigators
- Azize R Tunc, Assist Prof, Study director, Lokman Hekim UniversityBurcu Yanık, Professor, Study director, Ankara City Hospital BilkentHALE ÖZDEMİR, PT, MSc, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834255
- Sponsor's protocol ID
- TABED 1/ 2862/2026
- Other IDs
- Corresponding Author
- Acronym
- Hemiplegia
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.