About this trial
This study aims to investigate the effects of motor-cognitive interactive robot-assisted training on improving upper limb motor dysfunction after stroke. By observing different combinations of motor and cognitive components in the training, the study will clarify the relationship between the proportion of motor and cognitive elements and the recovery of upper limb motor function. The goal is to optimize the training protocol for upper limb rehabilitation robots and enhance their therapeutic outcomes.
Participants will be randomly assigned to one of three groups: motor-cognitive interactive robot-assisted training, motor-focused robot-assisted training, or conventional rehabilitation training. Training sessions will last 60 minutes, occur 5 times per week, and continue for 4 weeks. Researchers will measure changes in upper limb function and monitor for any adverse events during the training.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of stroke confirmed by CT or MRI.
Age between 40 and 80 years, with no gender restrictions.
First-ever stroke with unilateral limb paralysis.
Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
Disqualifiers
History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
Modified Ashworth Scale score > 2.
Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
Trial design
Parallel
Treatments tested in this trial
Motor-cognitive interactive robot
DeviceMotor-cognitive interactive robot-assisted training integrates motor and cognitive rehabilitation using an upper limb rehabilitation robot. If patients cannot actively lift the robotic arm, an eye-tracking mode detects movement intention and guides the arm along predefined trajectories, adjusting motor and cognitive loads dynamically. As motor function improves, training shifts to an active mode with increased resistance. Patients complete cognitive tasks before moving the robotic arm, while the system monitors movement parameters and provides real-time feedback. Training consists of 60-minute sessions, five days per week for four weeks. Motor load progresses by increasing robotic arm speed or resistance, while cognitive load advances based on task accuracy, ensuring personalized and adaptive rehabilitation.
Motor-focused robot
DeviceMotor-focused robot-assisted training primarily emphasizes motor rehabilitation through the use of an upper limb rehabilitation robot. When patients are unable to actively lift the robotic arm, an eye-tracking mode is employed to guide movements, with adjustments made solely to the motor load. As motor function improves, the training transitions to an active mode, progressively increasing resistance while maintaining a constant, minimal level of cognitive difficulty. Patients are required to complete cognitive tasks before initiating movement of the robotic arm, while the system monitors key movement parameters and provides real-time feedback. Training consists of 60-minute sessions, five days per week for four weeks. Motor load is progressively increased by adjusting the speed or resistance of the robotic arm, while cognitive load remains consistently at the lowest level throughout the training.
Conventional rehabilitation training
BehavioralConventional rehabilitation training adheres to internationally established guidelines and employs task-oriented approaches tailored to activities of daily living (ADLs). The therapeutic regimen incorporates fundamental motor skill exercises, including but not limited to grasp-and-release maneuvers, targeted reaching, fine motor skill development (e.g., button manipulation, zipper operation), and bilateral coordination tasks (e.g., garment folding, towel wringing). The intervention protocol emphasizes progressive task difficulty and functional task integration, with each session lasting 60 minutes. The treatment schedule consists of daily sessions, five times per week, over a four-week duration.
Treatment groups
Trial outcomes
Primary outcomes
Fugl-Meyer Upper Extremity Scale
Score range 0-66, higher scores indicate better upper limb motor recovery.
Secondary outcomes
Fugl-Meyer Upper Extremity Scale
Score range 0-66, higher scores indicate better upper limb motor recovery.
Upper limb kinematics during standardized 3D grid tasks
The investigators quantify upper limb kinematics using the robot through standardized 3D grid-pointing tasks to measure motion trajectories during task execution.
Upper Limb Muscle Strength Assessment
Muscle strength is assessed using Manual Muscle Testing (MMT) graded via the Medical Research Council (MRC) Scale (range: 0-5, where 0 = no muscle contraction and 5 = normal strength, higher scores indicate better outcomes).
Modified Barthel Index
Score range 0-100, higher scores indicate better independence in activities of daily living.
Other outcomes
Exercise-associated Blood Biomarkers
Quantitative measurement of exercise-associated biomarkers in venous blood using standardized ELISA kits
Multimodal Neuroimaging Analysis
Structural (T1-MPRAGE) and resting-state fMRI data acquired via 3T MRI. Structural analysis includes voxel-based morphometry (VBM) for gray matter volume. Functional analysis covers: ALFF, ReHo, FC, and graph-theory network topology (global/local efficiency).
Sponsors and contacts
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Lidian Chen
Lead sponsor
Fujian University of Traditional Chinese Medicine
Sponsor institution
Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital
Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborator
China Rehabilitation Research Center
Collaborator
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Collaborator
Shanghai Sunshine Rehabilitation Center
Collaborator