Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
NCT ID: NCT06435624
Last Updated: 2025-03-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
81 participants
INTERVENTIONAL
2024-06-15
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Proximal and Distal Robot-assisted Therapy Combined With Functional Training
NCT02254343
Robotic-assisted Therapy With Bilateral Practice Improves Task and Motor Performance of the Upper Extremity for Chronic Stroke Patients
NCT03847103
Visual Feedback Balance Training System Combined with RFE in Stroke
NCT06477445
Motor-Cognitive Interactive Upper Limb Robot Rehabilitation for Post-Stroke Motor Dysfunction
NCT06876597
Robot- Versus Mirror-Assisted Rehabilitation in Stroke Patients
NCT01724164
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
conventional therapy
Basic training, including passive joint movement and activities of daily living exercise.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanjing Mingzhou Rehabilitation Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jingzhi Zhang
technician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanjing Mingzhou Rehabilitation Hospital
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NJKF202401001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.