NRL Medical Center
Istanbul, Turkey (Türkiye)
NCT Number: NCT07760090
Loss of upper extremity and particularly hand function after stroke reduces independence in daily activities such as eating, dressing, and personal care. Robot-assisted hand rehabilitation provides repetitive, intensive, and task-oriented practice that supports motor learning, dexterity, and functional hand use. Motor imagery, the mental rehearsal of a movement without physically performing it, is thought to activate motor-related brain networks and to support motor learning and neuroplasticity. Evidence on the added value of combining motor imagery with robot-assisted hand rehabilitation for activities of daily living is limited. This randomized controlled trial will investigate whether motor imagery training added to robot-assisted hand rehabilitation produces greater improvement in activities of daily living than robot-assisted hand rehabilitation alone in individuals with stroke. Forty participants will be randomly allocated to an experimental group (robot-assisted hand rehabilitation plus motor imagery, n=20) or a control group (robot-assisted hand rehabilitation alone, n=20). Both groups will receive the same dose of robot-assisted hand rehabilitation with a soft robotic hand rehabilitation glove, three days per week for six weeks. Outcomes will be assessed at baseline and after the six-week program.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Istanbul, Turkey (Türkiye)
Design and setting This is a two-arm, parallel-group randomized controlled trial conducted at NRL Physical Therapy Medical Center. Institutional permission for the study site has been obtained.
Participants Forty individuals aged 18 years or older with a diagnosis of stroke and impairment of upper extremity and hand function will be enrolled. Written informed consent will be obtained from all participants before any study procedure. Randomization Participants will be allocated 1:1 to the experimental or the control group using a sealed envelope method, resulting in 20 participants per group. Interventions Both groups will receive robot-assisted hand rehabilitation delivered with a soft robotic hand rehabilitation glove (Syrebo). Sessions will be individual, supervised by a physiotherapist, delivered three days per week for six weeks, and will last approximately 40 to 60 minutes each. In addition to robot-assisted hand rehabilitation, participants in the experimental group will perform motor imagery training, in which they will be asked to mentally rehearse hand opening and closing, grasping, object holding, and hand movements used in daily life before physically performing them. Verbal guidance will be provided during motor imagery when needed. The control group will not receive motor imagery 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 the participant does not wish to continue. Outcome assessment Assessments will be performed before the start of the intervention program and repeated after the six-week program is completed. 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 of daily living will be assessed with the Barthel Index, hand function related activity limitation with the Duruoz Hand Index, gross manual dexterity with the Box and Block Test, and spasticity of the wrist and finger flexors with the Modified Ashworth Scale. Variables The independent variable is the rehabilitation program (robot-assisted hand rehabilitation alone versus robot-assisted hand rehabilitation plus motor imagery). The dependent variables are the Barthel Index score, the Duruoz Hand Index score, the Box and Block Test score, and the Modified Ashworth Scale grade. Statistical analysis Data will be 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 considered statistically significant. Sample size and effect size calculations were performed with G*Power. Ethics and data protection Personal information will be kept confidential, data will be recorded in coded form, and will be used for scientific purposes only. Participants may withdraw at any time. No blood sampling, drug administration, or surgical procedure will be performed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individual, physiotherapist-supervised robot-assisted hand rehabilitation delivered with a soft robotic hand rehabilitation glove (Syrebo), providing repetitive task-oriented hand opening, closing, and grasping practice. Three sessions per week for six weeks, approximately 40 to 60 minutes per session.
Mental rehearsal of hand opening and closing, grasping, object holding, and hand movements used in daily life, performed before the corresponding physical movement, with verbal guidance when needed. Delivered in the same sessions as robot-assisted hand rehabilitation, three days per week for six weeks.
Time frame: Baseline and after the six-week intervention program (week 6)
The Barthel Index assesses independence in basic activities of daily living including feeding, bathing, grooming, dressing, toilet use, transfers, walking, stair climbing, and bladder and bowel control. Total score ranges from 0 to 100. Higher scores indicate greater independence.
Uskudar University
Other
The Effect of Motor Imagery Training Added to Robot-Assisted Hand Rehabilitation on Activities of Daily Living in Patients With Stroke: A Randomized Controlled Trial
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