StrokeNCT06876597
Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction
A study testing Motor-cognitive interactive robot, Motor-focused robot and Conventional rehabilitation training in people with Stroke, run by Lidian Chen at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Motor-cognitive interactive robot, Motor-focused robot and Conventional rehabilitation training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,047 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stroke confirmed by CT or MRI.
- Age between 40 and 80 years, with no gender restrictions.
- First-ever stroke with unilateral limb paralysis.
- Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
- Willingness to participate and provide written informed consent.
Who cannot join
- History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
- Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
- Modified Ashworth Scale score > 2.
- Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
- Boston Diagnostic Aphasia Examination score < 3.
- Severe visual impairment preventing participation in upper limb robot-assisted rehabilitation training.
- Hamilton Depression Scale score >17, indicating moderate to severe depressive symptoms.
- Participation in other clinical trials that may interfere with the results of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian University of Traditional Chinese Medicine
Fuzhou, 350122
Jingsong Wu, 86+13609501214, 343872012@qq.com
About this study
Official title: Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
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.
- Conditions
- Stroke
- Being tested
- Motor-cognitive interactive robot, Motor-focused robot, Conventional rehabilitation training
- Keywords
- upeer, motor-cognitive interaction, robot
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor-cognitive interactive robotDevice
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 robotDevice
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motor-cognitive interactive robot-assisted training | Experimental | Not described Receives: Device: Motor-cognitive interactive robot |
| Motor-focused robot-assisted training | Experimental | Not described Receives: Device: Motor-focused robot |
| Conventional rehabilitation training | Experimental | Not described Receives: Behavioral: Conventional rehabilitation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Scale
Score range 0-66, higher scores indicate better upper limb motor recovery.
Measured: 4 weeks (post-intervention)
Secondary outcomes (9)
Fugl-Meyer Upper Extremity Scale
Score range 0-66, higher scores indicate better upper limb motor recovery.
Measured: 3 months (post-intervention follow-up)
Upper limb kinematics during standardized 3D grid tasks
The investigators quantify upper limb kinematics using the robot through standardized 3D grid-pointing tasks to measure motion trajectories during task execution.
Measured: 4 weeks
Upper Limb Muscle Strength Assessment
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).
Measured: 4 weeks, 3 months
Modified Barthel Index
Score range 0-100, higher scores indicate better independence in activities of daily living.
Measured: 4 weeks, 3 months
Montreal Cognitive Assessment
Score range 0-30, higher scores indicate better cognitive function.
Measured: 4 weeks, 3 months
Auditory Verbal Learning Test
Measured: 4 weeks, 3 months
Trail Making Test Part A
Measured: 4 weeks, 3 months
Trail Making Test Part B
Measured: 4 weeks, 3 months
Stroke-Specific Quality of Life Scale
Score range 49-245, higher scores indicate better health-related quality of life in stroke survivors.
Measured: 4 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start8 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,047 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lidian Chen
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, China Rehabilitation Research Center, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Shanghai Sunshine Rehabilitation Center
- Responsible party
- Sponsor-investigator, Lidian Chen, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876597
- Sponsor's protocol ID
- FujianUTCM-3
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-Cognitive Interactive Upper Limb Rehabilitation Robot Intervention for Post-Stroke Motor Dysfunction: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06876597
- Acronym / sponsor ID
- FujianUTCM-3
- Conditions
- Stroke
- Keywords
- upeer, motor-cognitive interaction, robot
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,047 participants (estimated)
- Lead sponsor
- Lidian ChenUniversity, hospital or other
- Collaborators
- Fujian University of Traditional Chinese Medicine Affiliated Rehabilitation Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, China Rehabilitation Research Center, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Shanghai Sunshine Rehabilitation Center
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motor-cognitive interactive robot-assisted training | Experimental | Device: Motor-cognitive interactive robot |
| Motor-focused robot-assisted training | Experimental | Device: Motor-focused robot |
| Conventional rehabilitation training | Experimental | Behavioral: Conventional rehabilitation training |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stroke confirmed by CT or MRI.
- Age between 40 and 80 years, with no gender restrictions.
- First-ever stroke with unilateral limb paralysis.
- Onset of stroke between 2 weeks and 6 months prior, with an FMA-UE score of 8-44.
- Willingness to participate and provide written informed consent.
Key exclusion criteria (8 listed)
- History of neuromuscular diseases, malignant tumors, or other severe uncontrolled conditions, including cardiac, renal, or hepatic diseases.
- Seated balance score < 2, or inability to maintain a sitting position for more than 60 minutes.
- Modified Ashworth Scale score > 2.
- Visual Analog Scale (VAS) score > 3 for hemiplegic shoulder pain.
- Boston Diagnostic Aphasia Examination score < 3.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-cognitive interactive robotMotor-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. | Device | Motor-cognitive interactive robot-assisted training |
| Motor-focused robotMotor-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. | Device | Motor-focused robot-assisted training |
| Conventional rehabilitation trainingConventional 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. | Behavioural | Conventional rehabilitation training |
Primary outcome
Fugl-Meyer Upper Extremity Scale
Time frame: 4 weeks (post-intervention)
Score range 0-66, higher scores indicate better upper limb motor recovery.
9 secondary outcomes
Fugl-Meyer Upper Extremity Scale
Time frame: 3 months (post-intervention follow-up)
Upper limb kinematics during standardized 3D grid tasks
Time frame: 4 weeks
Upper Limb Muscle Strength Assessment
Time frame: 4 weeks, 3 months
Modified Barthel Index
Time frame: 4 weeks, 3 months
Montreal Cognitive Assessment
Time frame: 4 weeks, 3 months
Auditory Verbal Learning Test
Time frame: 4 weeks, 3 months
Trail Making Test Part A
Time frame: 4 weeks, 3 months
Trail Making Test Part B
Time frame: 4 weeks, 3 months
Stroke-Specific Quality of Life Scale
Time frame: 4 weeks, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor-cognitive interactive robot, Motor-focused robot and Conventional rehabilitation training in people with Stroke, run by Lidian Chen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingsong Wu (86+13609501214, jingsongwu01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Scale (time frame: 4 weeks (post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.