This study aims to investigate whether combining "motor imagery" (the mental visualization of movement) with robotic exoskeleton therapy can improve upper limb recovery in stroke patients. Conventional robotic therapy often involves passive movement driven by the machine. In this study, patients in the experimental group will use their own voice to trigger the robot (e.g., saying "bend arm") while simultaneously imagining the movement. The research will compare this voice-enhanced "active" approach with traditional passive robotic training to see if it better promotes brain-to-muscle signal recovery and improves overall arm function .
Background and Rationale: Stroke is a leading cause of adult disability, and the "golden period" for rehabilitation requires intensive therapy to trigger muscle movement. Recent theories suggest that combining motor imagery with physical activity-known as Brain-Computer Interface (BCI) concepts-may be more effective than passive movement alone. However, complex EEG-based BCI is difficult to implement clinically. This study proposes a simplified "voice-controlled" interface to simulate the motor intent-to-action loop. Study Design: This is a randomized, assessor-blinded, parallel-group clinical trial involving 32 subacute or chronic stroke patients. Participants will be randomly assigned to one of two groups for a 4-week intervention (5 sessions per week, 30 minutes per session). Interventions: Experimental Group (Voice + Exoskeleton): Patients will use the Nimbo single-joint robot. Before each movement, they will focus on imagining the target action for 2 seconds, then issue a standardized voice command (e.g., "bend hand") to trigger the robotic assistance. Control Group (Passive Exoskeleton): Patients will receive conventional robotic-assisted training where the Nimbo exoskeleton moves the limb through a preset path without voice prompts or intentional imagery requirements. Outcome Measures: Evaluations will be conducted at baseline (T0), week 2 (T1), and week 4 (T2). Primary Outcome: Upper limb motor function measured by the Fugl-Meyer Assessment - Upper Extremity (FMA-UE). Secondary Outcomes: Brunnstrom stage (recovery phase), KVIQ-10 (subjective imagery), Laterality Judgment Task (objective imagery processing), Sense of Agency (SoA) questionnaire, and System Usability Scale (SUS). Safety and Monitoring: Safety checks, including pain (NRS), fatigue (RPE), and skin inspections, will be performed after every session. Any adverse events will be reported to the Institutional Review Board (IRB) and data safety monitoring personnel .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
A robotic exoskeleton used with a voice-trigger interface. Patients perform motor imagery for 2 seconds followed by a voice command to activate the device.
The same robotic exoskeleton used in a traditional passive rehabilitation mode where the device moves the limb automatically according to preset parameters.
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
A quantitative measure of upper limb motor recovery. The scale includes 33 items assessing reflexes, movement patterns, and coordination. Scores range from 0 to 66, with higher scores indicating better motor function.
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Brunnstrom Recovery Stage (Upper Limb)
A 6-stage classification system used to categorize the degree of motor recovery in post-stroke hemiplegia, ranging from Stage I (flaccidity) to Stage VI (normal motor function).
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Kinesthetic and Visual Imagery Questionnaire (KVIQ-10)
Evaluates the clarity of visual imagery and intensity of kinesthetic imagery on a 5-point scale. Scores range from 10 to 50; higher scores indicate better imagery ability.
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Laterality Judgment Task (LJT) - Accuracy and Reaction Time
Measures the mental rotation ability by identifying the laterality (left/right) of hand images. Accuracy (percentage) and reaction time (seconds) are recorded.
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
Sense of Agency (SoA) Questionnaire
This questionnaire assesses the patient's subjective feeling of control over the robotic movement. It consists of 4 items scored on a 7-point Likert scale, ranging from -3 (strongly disagree) to +3 (strongly agree). The total score is the sum of all items, ranging from -12 to +12. Higher scores indicate a stronger sense of agency (a greater feeling of being the cause of the robotic movement).
Time frame: Baseline (T0), 2 weeks (T1), and 4 weeks (T2).
System Usability Scale (SUS)
The System Usability Scale (SUS) is a 10-item instrument for evaluating the usability of the voice-controlled robotic interface. Each item is scored on a 5-point scale from 0 (strongly disagree) to 4 (strongly agree). The final score is calculated by multiplying the sum of the item scores by 2.5, resulting in a total score ranging from 0 to 100. Higher scores indicate better usability and higher user satisfaction.
Time frame: 4 weeks (T2).
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