Effect of Hybrid Robot-assisted Training Using End-effector and Exoskeleton Devices in Distal Upper Extremity After Stroke:Motor Control, Motor and Daily Function, Quality of Life

  • STATUS
    Recruiting
  • End date
    Oct 8, 2025
  • participants needed
    70
  • sponsor
    Chang Gung Memorial Hospital
Updated on 13 March 2022

Summary

The purpose of this study is to examine the immediate and long-term effects of hybrid robot-assisted training (Hybrid-RT), exoskeleton robot-assisted training (Exo-RT), end-effector robot-assisted training (EE-RT), and conventional training on stroke patients' motor performance, daily life functions, quality of life, and self-efficacy.

Description

Stroke is a leading cause of long-term disability, and most stroke survivors have chronic upper limb dysfunction, which affects participation in activities of daily living. In addition to conventional rehabilitation training, robot-assisted training has been advocated as a contemporary approach of hand function training. Robotic devices can be categorized into exoskeleton and end-effector types based on their mechanical design. However, previous studies did not reach an agreement on the effectiveness of two types of robot-assisted training. The study firstly proposes a hybrid robot-assisted training program, which combines two types of robotic systems, to enhance the effectiveness of robot-assisted training and provide a new approach for motor training of upper limb in stroke patients. Secondly, the relative effects of the two types of robot-assisted training will be compared. The purpose of this study is to examine the immediate and long-term effects of hybrid robot-assisted training , exoskeleton robot-assisted training , end-effector robot-assisted training , and conventional training on stroke patients' motor performance, daily life functions, quality of life, and self-efficacy. The study will recruit stroke patients and randomly assign them to the hybrid robot-assisted training, exoskeleton robot-assisted training, end-effector robot-assisted training, and conventional training groups. Each participant will receive training 3 sessions a week for 6 consecutive weeks. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance will be used to evaluate the changes within each intervention group at three evaluation times and to compare the differences between the four intervention groups. In order to understand the motor learning effects after receiving different interventions, the investigator use kinematic analysis to investigate the movement control mechanism of upper limb movements. The findings of this study will build the evidence-based foundation for bridging the gap between basic science and clinical application.

Details
Condition Stroke
Treatment robot-assisted, Conventional rehabilitation intervention
Clinical Study IdentifierNCT05226988
SponsorChang Gung Memorial Hospital
Last Modified on13 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Stroke more than 3 months
Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms
The myoelectric signal can be detected to activate the instrument
Unilateral paresis (FMA score<60)
No serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
Can provide informed consent

Exclusion Criteria

Other neurological disease
Complete sense of body defect
Inability to understand instructions
current participation in any other research
Botulinum Toxin injection within 3 months
Clear my responses

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