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OpenTrials
Completed

NCT Number: NCT06435624

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Mingzhou Rehabilitation Hospital

Nanjing, Jiangsu, 210046, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intelligent robotic-assisted training

Device

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

Other

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

Other

Basic training, including passive joint movement and activities of daily living exercise.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Nanjing Mingzhou Rehabilitation Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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