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Completed
NCT07834255
The Effect of Robotic Rehabilitation in Stroke Patients
Conditions: Subacute Stroke, Stroke, Ischemic Stroke, Hemorrhagic Stroke
Sex: All
Ages: 35 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Lokman Hekim University
Location: Ankara Bilkent City Hospital Physical Medicine and Rehabilitation Hospital Ankara Çankaya
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07834255). StuddyBuddy aggregates publicly available trial information.