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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IRAT group | Experimental | The Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention. |
|
| RFE group | Active Comparator | The Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention. |
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| CT group | Active Comparator | The Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intelligent robotic-assisted training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at 4 weeks |
| 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. | From enrollment to the end of treatment at 4 weeks |
| 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. | From enrollment to the end of treatment at 4 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Mingzhou Rehabilitation Hospital | Nanjing | Jiangsu | 210046 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40611355 | Derived | Zhang JZ, Chen J, Liu XL, Yan LB, Xu SM. Effectiveness of intelligent robotic-assisted training system combined with repetitive facilitative exercise on upper limb motor function after stroke: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Jul 3;17(1):178. doi: 10.1186/s13102-025-01234-y. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2024 |
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| repetitive facilitative exercise | Other | 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. |
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| conventional therapy | Other | Basic training, including passive joint movement and activities of daily living exercise. |
|
| From enrollment to the end of treatment at 4 weeks |
| FG001 | 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. |
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Affected side, left/right | Number | participants |
| ||||||||||||||||
| Time from stroke, days | Mean | Standard Deviation | days |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | From enrollment to the end of treatment at 4 weeks |
|
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| 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. | Posted | Mean | Standard Deviation | percentage of active participation | From enrollment to the end of treatment at 4 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | millimeter | From enrollment to the end of treatment at 4 weeks |
| ||||||||||||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | millimeter | From enrollment to the end of treatment at 4 weeks |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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The intervention period was relatively short and lacked long-term follow-up.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jingzhi Zhang | Nanjing Mingzhou Rehabilitation Hospital | 16677137704 | 86 | 170787717@qq.com |
| Jan 4, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| right |
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| OG002 | 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. |
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| OG002 | 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. |
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| OG002 | 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. |
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