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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: repetitive facilitative exercise; Other: conventional therapy; Device: intelligent robotic-assisted training

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210046
      • Nanjing Mingzhou Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IRAT group; The Intelligent robotic-assisted training (IRAT) group received a 30 minute RFE intervention and a 30 minute IRAT intervention.	Other: 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.; Device: 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.
Active Comparator: RFE group; The Repetitive facilitative exercise (RFE) group received a 60 minute RFE intervention.	Other: 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.
Active Comparator: CT group; The Conventional therapy (CT) group received a 60 minute conventional rehabilitation intervention.	Other: conventional therapy; Basic training, including passive joint movement and activities of daily living exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion (ROM)		From enrollment to the end of treatment at 4 weeks
Modified Ashworth Scale (MAS)	The MAS score was used to evaluate spasticity of the affected upper limb. The higher the score of MAS (0, 1, 1+, 2, 3 and 4), the higher the degree of spasms.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Nanjing Mingzhou Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2024
• Primary Completion (Actual): August 31, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: NJKF202401001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No