The Effect of Robotic Rehabilitation in Stroke Patients

NCT07834255 | Completed

• 2 other identifiers: TABED 1/ 2862/2026Corresponding Author
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Subacute Stroke; Stroke; Ischemic Stroke; Hemorrhagic Stroke

Keywords

Hemiplegia; Shoulder Pain; Stroke Rehabilitation; Upper Extremity; Cognitive Remediation

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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

  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.

  Baseline and 6 weeks

Other Outcomes (1)

• Demographic Information Form

  Baseline

Study Arms (2)

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.

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.

Other: Conventional Physiotherapy

Interventions

Robot-Assisted Upper Extremity Therapy 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.

Also known as: Armeopower upper extremity robotic device

The Robotic Therapy Group

Conventional Physiotherapy OTHER

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.

The Conventional Therapy Group; The Robotic Therapy Group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lokman Hekim University: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Hemiplegia; Shoulder Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain

Study Officials

• Azize R Tunc, Assist Prof

  Lokman Hekim University

  STUDY DIRECTOR

• Burcu Yanık, Professor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

• HALE ÖZDEMİR, PT, MSc

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 22, 2026
• Study Start: January 2, 2026
• Primary Completion: March 20, 2026
• Study Completion: May 4, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

TU (1)