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

Not Applicable

Completed

Conditions: Stroke

Interventions: Other: repetitive facilitative exercise
Device: intelligent rehabilitation robot training system
Other: conventional therapy

Registration Number: NCT06435624

Lead Sponsor: Nanjing Mingzhou Rehabilitation Hospital

Brief 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. 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 81

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFE group	repetitive facilitative exercise	Repetitive facilitative exercise (RFE)
Combined group	intelligent rehabilitation robot training system	Intelligent rehabilitation robot training system under repetitive facilitative exercise (RFE)
CT group	conventional therapy	Conventional therapy (CT)
Combined group	repetitive facilitative exercise	Intelligent rehabilitation robot training system under repetitive facilitative exercise (RFE)

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)	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	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	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	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.