Fujian University of Traditional Chinese Medicine
Fuzhou, 350122, China
Location status: Recruiting
NCT Number: NCT06876597
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Not applicable
Fuzhou, 350122, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Motor-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-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 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.
Time frame: 4 weeks (post-intervention)
Score range 0-66, higher scores indicate better upper limb motor recovery.
Time frame: 3 months (post-intervention follow-up)
Score range 0-66, higher scores indicate better upper limb motor recovery.
Time frame: 4 weeks
The investigators quantify upper limb kinematics using the robot through standardized 3D grid-pointing tasks to measure motion trajectories during task execution.
Time frame: 4 weeks, 3 months
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).
Time frame: 4 weeks, 3 months
Score range 0-100, higher scores indicate better independence in activities of daily living.
Time frame: 4 weeks, 3 months
Score range 0-30, higher scores indicate better cognitive function.
Time frame: 4 weeks, 3 months
Time frame: 4 weeks, 3 months
Time frame: 4 weeks, 3 months
Time frame: 4 weeks, 3 months
Score range 49-245, higher scores indicate better health-related quality of life in stroke survivors.
Time frame: 4 weeks
Quantitative measurement of exercise-associated biomarkers in venous blood using standardized ELISA kits
Time frame: 4 weeks
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).
Contact information is provided by the study sponsor or research team.
Lidian Chen
Other
Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06615973
Brain Disease, Brain Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT05378035
Arrhythmias, Cardiac, Arterial Thromboembolism
Hong Kong
View Trial DetailsNCT03821129
Brain Diseases, Cardiovascular Abnormalities
Tucson, Arizona, United States
View Trial DetailsNCT07737431
Brain Diseases, Cardiovascular Diseases
Hung Hom, Kowloon, Hong Kong
View Trial Details