The Effect of Robotic Rehabilitation in Stroke Patients

Lokman Hekim University36 enrolled

Overview

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.

Interventions

Robot-Assisted Upper Extremity TherapyDEVICE

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.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.