StrokeNCT06435624

Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.

A study testing intelligent robotic-assisted training, repetitive facilitative exercise and conventional therapy in people with Stroke, run by Nanjing Mingzhou Rehabilitation Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Stroke
What is being tested?: intelligent robotic-assisted training, repetitive facilitative exercise and conventional therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 81 participants
Where: 1 siteChina
Study dates: 15 Jun 2024to 31 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Nanjing Mingzhou Rehabilitation Hospital
Nanjing, Jiangsu, 210046

Other trials in China

About this study

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

Conditions: Stroke
Being tested: intelligent robotic-assisted training, repetitive facilitative exercise, conventional therapy
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

intelligent robotic-assisted trainingDevice
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 exerciseOther
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 therapyOther
Basic training, including passive joint movement and activities of daily living exercise.

Study groups in NCT06435624
Study group	Role	What they receive
IRAT group	Experimental	The Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention. Receives: Device: intelligent robotic-assisted training; Other: repetitive facilitative exercise
RFE group	Active comparator	The Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention. Receives: Other: repetitive facilitative exercise
CT group	Active comparator	The Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention. Receives: Other: conventional therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 202431 Aug 2024

First posted30 May 2024
Study start15 Jun 2024
Primary completion31 Aug 2024
Study completion31 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06435624
Sponsor's protocol ID: NJKF202401001
Status last verified: Feb 2025
First submitted: 21 May 2024
Last updated: 5 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40611355

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Intelligent Rehabilitation Robot Training System Combined With Repetitive Facilitative Exercise on Upper Limb Motor Function After Stroke: a Randomized Control Trial.
ClinicalTrials.gov ID: NCT06435624
Acronym / sponsor ID: NJKF202401001
Conditions: Stroke
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Nanjing Mingzhou Rehabilitation HospitalUniversity, hospital or other
Study start: 15 Jun 2024 (actual)
Primary completion: 31 Aug 2024 (actual)
Study completion: 31 Aug 2024 (actual)
First posted: 30 May 2024 (actual)
Results: Posted 5 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Participants will:

Receive treatment for 4 weeks Receive scale and instrument testing before and after treatment

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
IRAT group	Experimental	Device: intelligent robotic-assisted training, Other: repetitive facilitative exerciseThe Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention.
RFE group	Active comparator	Other: repetitive facilitative exerciseThe Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention.
CT group	Active comparator	Other: conventional therapyThe Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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

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
intelligent robotic-assisted trainingUsing 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.	Device	IRAT group
repetitive facilitative exerciseRepetitive 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.	Other	IRAT group, RFE group
conventional therapyBasic training, including passive joint movement and activities of daily living exercise.	Other	CT group

Primary outcome

Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 5 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IRAT Group	27	25
RFE Group	27	26
CT Group	27	25

Primary outcome: Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

Time frame: From enrollment to the end of treatment at 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	IRAT Group n = 25	RFE Group n = 26	CT Group n = 25
baseline	34.4 (3.5)	34.9 (3.8)	35.8 (3.9)
4 weeks	49.0 (3.3)	44.2 (3.6)	38.8 (3.8)

Primary outcome: Active Participation Proportion

Time frame: From enrollment to the end of treatment at 4 weeks. Mean (Standard Deviation). Unit: percentage of active participation

Measure	IRAT Group n = 25	RFE Group n = 26	CT Group n = 25
baseline	61.7 (4.8)	104.0 (7.9)	60.8 (6.1)
4 weeks	80.4 (5.3)	61.6 (2.8)	60.9 (2.6)

Primary outcome: Trajectory Deviation

Time frame: From enrollment to the end of treatment at 4 weeks. Mean (Standard Deviation). Unit: millimeter

Measure	IRAT Group n = 25	RFE Group n = 26	CT Group n = 25
baseline	104.0 (7.9)	100.7 (8.9)	99.5 (8.3)
4 weeks	65.7 (8.0)	98.1 (5.7)	95.7 (4.7)

Primary outcome: Trajectory Tracking Error

Time frame: From enrollment to the end of treatment at 4 weeks. Mean (Standard Deviation). Unit: millimeter

Measure	IRAT Group n = 25	RFE Group n = 26	CT Group n = 25
baseline	60.8 (6.1)	60.5 (6.0)	61.6 (5.8)
4 weeks	36.8 (6.6)	58.0 (2.8)	59.1 (2.8)

Adverse events

Time frame: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
IRAT Group	0 of 0	0 of 0
RFE Group	0 of 0	0 of 0
CT Group	0 of 0	0 of 0

Limitations and caveats (from the sponsor): The intervention period was relatively short and lacked long-term follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40611355Zhang 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.

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
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Not yet recruiting
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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: finished, as of the sponsor's last update on 5 Mar 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?

Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06435624, which also lists 1 linked publication.

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 5 Mar 2025.