Stroke
Conditions
Brief summary
The goal of this clinical trial is to learn if intelligent rehabilitation robot training system combined with repetitive facilitative exercise (RFE) work to treat stroke in adults. The main questions it aims to answer are: Does drug intelligent rehabilitation robot training system combined with RFE improve the upper limb motor function of participants? Can the combination of intelligent rehabilitation robot training system and RFE achieve better effects? Researchers will compare 3 groups (RFE, intelligent rehabilitation robot training system under RFE, and conventional therapy) to see if intelligent rehabilitation robot training system and RFE works to treat stroke. Participants will: Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment
Interventions
DEVICEintelligent robotic-assisted training
Using an intelligent robotic-assisted training (IRAT) system to simulate a real work environment, providing functional oriented treatment for stroke patients and improving upper limb motor function. The instrument used is the Burt upper limb robot training system produced by Estun Medical Co., Ltd.
Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise.
OTHERconventional therapy
Basic training, including passive joint movement and activities of daily living exercise.
Sponsors
Nanjing Mingzhou Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* patients (18 to 74 years old) who suffered a first or second unilateral stroke * chronic stroke (over 6 months from the onset) * obvious upper limb movement disorders (FMA-UE scores from 25 to 42) * ability to understand and follow simple directions
Exclusion criteria
* pregnant or lactating * upper extremity contracture, pain, or trauma * perceptual, apraxic, or cognitive deficits that lead to inability to follow verbal instructions * unable to maintain sitting posture * cerebellar lesion * clinically unstable medical disorders * inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | From enrollment to the end of treatment at 4 weeks | The FMA-UE consists of 33 items across nine components, including reflex action, synergy, and coordination, with a maximum score of 66 points. Each items is scored from 0 (no ability) to 2 (full ability), with higher scores indicating better upper limb motor function. |
| Active Participation Proportion | From enrollment to the end of treatment at 4 weeks | Active Participation Proportion (APP) is measured using the benchmark evaluation system within the intelligent rehabilitation robot training system. The robotic arm's mechanical sensor continuously detects the force exerted by the patient during the test game and quantifies APP as the ratio of the patient's applied force to the total force required to complete the task (%). A higher APP indicates greater voluntary effort in movement execution. Since the test game difficulty is fixed, APP increases as the patient's motor ability improves. |
| Trajectory Deviation | From enrollment to the end of treatment at 4 weeks | Trajectory Deviation (TD) is assessed by comparing the actual motion trajectory with a predefined reference trajectory using the intelligent rehabilitation robot training system. TD is calculated as the mean Euclidean distance (in mm) between discrete points along the actual movement path and the nearest corresponding points on the reference trajectory. This metric provides a measure of point-specific accuracy and precision in following the ideal movement path, with smaller TD values indicating better trajectory control. |
| Trajectory Tracking Error | From enrollment to the end of treatment at 4 weeks | Description: Trajectory Tracking Error (TTE) quantifies the cumulative deviation between the actual movement path and the predefined reference trajectory. It is computed as the sum of absolute differences in trajectory length between the two paths (in mm). TTE reflects overall movement efficiency and smoothness, capturing the patient's ability to maintain an optimal movement path throughout the task. A lower TTE indicates better movement planning and motor control. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| IRAT Group The Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention.
intelligent robotic-assisted training: Using an intelligent robotic-assisted training (IRAT) system to simulate a real work environment, providing functional oriented treatment for stroke patients and improving upper limb motor function.
The instrument used is the Burt upper limb robot training system produced by Estun Medical Co., Ltd.
repetitive facilitative exercise: Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise. | 25 |
| RFE Group The Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention.
repetitive facilitative exercise: Repetitive facilitative exercise (RFE) is a new technology that combines multiple sensory stimuli and achieves facilitation and reinforcement of the reconstruction of paralyzed neural pathways through repeated and extensive directional exercise. | 26 |
| CT Group The Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention.
conventional therapy: Basic training, including passive joint movement and activities of daily living exercise. | 25 |
| Total | 76 |
Baseline characteristics
| Characteristic | IRAT Group | RFE Group | Total | CT Group |
|---|---|---|---|---|
| Affected side, left/right left | 12 participants | 12 participants | 38 participants | 14 participants |
| Affected side, left/right right | 13 participants | 14 participants | 38 participants | 11 participants |
| Age, Continuous | 51.6 years STANDARD_DEVIATION 12.3 | 46.8 years STANDARD_DEVIATION 11.7 | 49.5 years STANDARD_DEVIATION 12.7 | 50.3 years STANDARD_DEVIATION 14 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 26 Participants | 76 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 25 participants | 26 participants | 76 participants | 25 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 29 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 47 Participants | 16 Participants |
| Time from stroke, days | 256.2 days STANDARD_DEVIATION 60.1 | 254.7 days STANDARD_DEVIATION 46 | 260.3 days STANDARD_DEVIATION 53.9 | 270.1 days STANDARD_DEVIATION 55.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Active Participation Proportion
Active Participation Proportion (APP) is measured using the benchmark evaluation system within the intelligent rehabilitation robot training system. The robotic arm's mechanical sensor continuously detects the force exerted by the patient during the test game and quantifies APP as the ratio of the patient's applied force to the total force required to complete the task (%). A higher APP indicates greater voluntary effort in movement execution. Since the test game difficulty is fixed, APP increases as the patient's motor ability improves.
Time frame: From enrollment to the end of treatment at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IRAT Group | Active Participation Proportion | baseline | 61.7 percentage of active participation | Standard Deviation 4.8 |
| IRAT Group | Active Participation Proportion | 4 weeks | 80.4 percentage of active participation | Standard Deviation 5.3 |
| RFE Group | Active Participation Proportion | baseline | 104.0 percentage of active participation | Standard Deviation 7.9 |
| RFE Group | Active Participation Proportion | 4 weeks | 61.6 percentage of active participation | Standard Deviation 2.8 |
| CT Group | Active Participation Proportion | baseline | 60.8 percentage of active participation | Standard Deviation 6.1 |
| CT Group | Active Participation Proportion | 4 weeks | 60.9 percentage of active participation | Standard Deviation 2.6 |
Primary
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
The FMA-UE consists of 33 items across nine components, including reflex action, synergy, and coordination, with a maximum score of 66 points. Each items is scored from 0 (no ability) to 2 (full ability), with higher scores indicating better upper limb motor function.
Time frame: From enrollment to the end of treatment at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IRAT Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 4 weeks | 49.0 score on a scale | Standard Deviation 3.3 |
| IRAT Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | baseline | 34.4 score on a scale | Standard Deviation 3.5 |
| RFE Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | baseline | 34.9 score on a scale | Standard Deviation 3.8 |
| RFE Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 4 weeks | 44.2 score on a scale | Standard Deviation 3.6 |
| CT Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | baseline | 35.8 score on a scale | Standard Deviation 3.9 |
| CT Group | Fugl-Meyer Assessment for Upper Extremity (FMA-UE) | 4 weeks | 38.8 score on a scale | Standard Deviation 3.8 |
Primary
Trajectory Deviation
Trajectory Deviation (TD) is assessed by comparing the actual motion trajectory with a predefined reference trajectory using the intelligent rehabilitation robot training system. TD is calculated as the mean Euclidean distance (in mm) between discrete points along the actual movement path and the nearest corresponding points on the reference trajectory. This metric provides a measure of point-specific accuracy and precision in following the ideal movement path, with smaller TD values indicating better trajectory control.
Time frame: From enrollment to the end of treatment at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IRAT Group | Trajectory Deviation | baseline | 104.0 millimeter | Standard Deviation 7.9 |
| IRAT Group | Trajectory Deviation | 4 weeks | 65.7 millimeter | Standard Deviation 8 |
| RFE Group | Trajectory Deviation | baseline | 100.7 millimeter | Standard Deviation 8.9 |
| RFE Group | Trajectory Deviation | 4 weeks | 98.1 millimeter | Standard Deviation 5.7 |
| CT Group | Trajectory Deviation | baseline | 99.5 millimeter | Standard Deviation 8.3 |
| CT Group | Trajectory Deviation | 4 weeks | 95.7 millimeter | Standard Deviation 4.7 |
Primary
Trajectory Tracking Error
Description: Trajectory Tracking Error (TTE) quantifies the cumulative deviation between the actual movement path and the predefined reference trajectory. It is computed as the sum of absolute differences in trajectory length between the two paths (in mm). TTE reflects overall movement efficiency and smoothness, capturing the patient's ability to maintain an optimal movement path throughout the task. A lower TTE indicates better movement planning and motor control.
Time frame: From enrollment to the end of treatment at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IRAT Group | Trajectory Tracking Error | baseline | 60.8 millimeter | Standard Deviation 6.1 |
| IRAT Group | Trajectory Tracking Error | 4 weeks | 36.8 millimeter | Standard Deviation 6.6 |
| RFE Group | Trajectory Tracking Error | baseline | 60.5 millimeter | Standard Deviation 6 |
| RFE Group | Trajectory Tracking Error | 4 weeks | 58.0 millimeter | Standard Deviation 2.8 |
| CT Group | Trajectory Tracking Error | baseline | 61.6 millimeter | Standard Deviation 5.8 |
| CT Group | Trajectory Tracking Error | 4 weeks | 59.1 millimeter | Standard Deviation 2.8 |