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N/A Completed N=81 Randomized Single-blind Treatment

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

Source: ClinicalTrials.gov NCT06435624 ↗
Enrolled (actual)
81
Serious AEs
Results posted
Mar 2025
Primary outcomePrimary: Fugl-Meyer Assessment for Upper Extremity (FMA-UE) — 34.4; 34.9; 35.8; 49.0 score on a scale

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Fugl-Meyer Assessment for Upper Extremity (FMA-UE)
34.4; 34.9; 35.8; 49.0; 44.2; 38.8
PRIMARY
Active Participation Proportion
61.7; 104.0; 60.8; 80.4; 61.6; 60.9
PRIMARY
Trajectory Deviation
104.0; 100.7; 99.5; 65.7; 98.1; 95.7
PRIMARY
Trajectory Tracking Error
60.8; 60.5; 61.6; 36.8; 58.0; 59.1

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06435624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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