Authors
»
Uskudar University -More
Category
»
Primary study
Registry of Trials»ClinicalTrials.gov
Year
»
2026
Design and setting This is a two‐arm, parallel‐group randomized controlled trialconducted at NRL Physical Therapy Medical Center. Institutional permission for the studysite has been obtained.Participants Forty individuals aged 18 years or older with a diagnosis of stroke andimpairment of upper extremity and hand function will be enrolled. Written informedconsent will be obtained from all participants before any study procedure. RandomizationParticipants will be allocated 1:1 to the experimental or the control group using asealed envelope method, resulting in 20 participants per group. Interventions Both groupswill receive robot‐assisted hand rehabilitation delivered with a soft robotic handrehabilitation glove (Syrebo). Sessions will be individual, supervised by aphysiotherapist, delivered three days per week for six weeks, and will last approximately40 to 60 minutes each. In addition to robot‐assisted hand rehabilitation, participants inthe experimental group will perform motor imagery training, in which they will be askedto mentally rehearse hand opening and closing, grasping, object holding, and handmovements used in daily life before physically performing them. Verbal guidance will beprovided during motor imagery when needed. The control group will not receive motorimagery training. Attendance will be monitored by the investigator using a session log.Sessions will be terminated in case of pain, excessive fatigue, discomfort, or if theparticipant does not wish to continue. Outcome assessment Assessments will be performedbefore the start of the intervention program and repeated after the six‐week program iscompleted. A sociodemographic and clinical information form will record age, sex,education, marital status, occupation, time since stroke, affected side, hand dominance,comorbidities, medications, and previous rehabilitation. Independence in activities ofdaily living will be assessed with the Barthel Index, hand function related activitylimitation with the Duruoz Hand Index, gross manual dexterity with the Box and BlockTest, and spasticity of the wrist and finger flexors with the Modified Ashworth Scale.Variables The independent variable is the rehabilitation program (robot‐assisted handrehabilitation alone versus robot‐assisted hand rehabilitation plus motor imagery). Thedependent variables are the Barthel Index score, the Duruoz Hand Index score, the Box andBlock Test score, and the Modified Ashworth Scale grade. Statistical analysis Data willbe analysed with SPSS version 23.0. Descriptive statistics will be presented as mean,standard deviation, frequency, and percentage. A p value below 0.05 will be consideredstatistically significant. Sample size and effect size calculations were performed withG*Power. Ethics and data protection Personal information will be kept confidential, datawill be recorded in coded form, and will be used for scientific purposes only.Participants may withdraw at any time. No blood sampling, drug administration, orsurgical procedure will be performed.
Epistemonikos ID: f23685e8b242c0076b173b23f9c2e77551224289
First added on: Aug 12, 2026