Trial Outcomes & Findings for Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial. (NCT NCT06435624)
NCT ID: NCT06435624
Last Updated: 2025-03-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
81 participants
Primary outcome timeframe
From enrollment to the end of treatment at 4 weeks
Results posted on
2025-03-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
27
|
27
|
27
|
|
Overall Study
COMPLETED
|
25
|
26
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
Baseline characteristics by cohort
| Measure |
IRAT Group
n=25 Participants
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.
|
RFE Group
n=26 Participants
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.
|
CT Group
n=25 Participants
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.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
25 participants
n=5 Participants
|
76 participants
n=4 Participants
|
|
Affected side, left/right
left
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
14 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Affected side, left/right
right
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Time from stroke, days
|
256.2 days
STANDARD_DEVIATION 60.1 • n=5 Participants
|
254.7 days
STANDARD_DEVIATION 46.0 • n=7 Participants
|
270.1 days
STANDARD_DEVIATION 55.8 • n=5 Participants
|
260.3 days
STANDARD_DEVIATION 53.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 4 weeksThe 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.
Outcome measures
| Measure |
IRAT Group
n=25 Participants
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.
|
RFE Group
n=26 Participants
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.
|
CT Group
n=25 Participants
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.
|
|---|---|---|---|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
baseline
|
34.4 score on a scale
Standard Deviation 3.5
|
34.9 score on a scale
Standard Deviation 3.8
|
35.8 score on a scale
Standard Deviation 3.9
|
|
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
4 weeks
|
49.0 score on a scale
Standard Deviation 3.3
|
44.2 score on a scale
Standard Deviation 3.6
|
38.8 score on a scale
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 4 weeksActive 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.
Outcome measures
| Measure |
IRAT Group
n=25 Participants
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.
|
RFE Group
n=26 Participants
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.
|
CT Group
n=25 Participants
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.
|
|---|---|---|---|
|
Active Participation Proportion
baseline
|
61.7 percentage of active participation
Standard Deviation 4.8
|
104.0 percentage of active participation
Standard Deviation 7.9
|
60.8 percentage of active participation
Standard Deviation 6.1
|
|
Active Participation Proportion
4 weeks
|
80.4 percentage of active participation
Standard Deviation 5.3
|
61.6 percentage of active participation
Standard Deviation 2.8
|
60.9 percentage of active participation
Standard Deviation 2.6
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 4 weeksTrajectory 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.
Outcome measures
| Measure |
IRAT Group
n=25 Participants
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.
|
RFE Group
n=26 Participants
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.
|
CT Group
n=25 Participants
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.
|
|---|---|---|---|
|
Trajectory Deviation
baseline
|
104.0 millimeter
Standard Deviation 7.9
|
100.7 millimeter
Standard Deviation 8.9
|
99.5 millimeter
Standard Deviation 8.3
|
|
Trajectory Deviation
4 weeks
|
65.7 millimeter
Standard Deviation 8.0
|
98.1 millimeter
Standard Deviation 5.7
|
95.7 millimeter
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: From enrollment to the end of treatment at 4 weeksDescription: 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.
Outcome measures
| Measure |
IRAT Group
n=25 Participants
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.
|
RFE Group
n=26 Participants
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.
|
CT Group
n=25 Participants
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.
|
|---|---|---|---|
|
Trajectory Tracking Error
baseline
|
60.8 millimeter
Standard Deviation 6.1
|
60.5 millimeter
Standard Deviation 6.0
|
61.6 millimeter
Standard Deviation 5.8
|
|
Trajectory Tracking Error
4 weeks
|
36.8 millimeter
Standard Deviation 6.6
|
58.0 millimeter
Standard Deviation 2.8
|
59.1 millimeter
Standard Deviation 2.8
|
Adverse Events
IRAT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RFE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CT Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place