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

NCT ID: NCT05226988

Last Updated: 2022-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-10-08

Brief 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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Hybrid-RT

hybrid robot-assisted training

Group Type: EXPERIMENTAL

robot-assisted

Intervention Type: DEVICE

Participants received the 18-session robot-assisted intervention 3 sessions a week for 6 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.

Exo-RT

exoskeleton robot-assisted training

Group Type: EXPERIMENTAL

robot-assisted

Intervention Type: DEVICE

Participants received the 18-session robot-assisted intervention 3 sessions a week for 6 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.

EE-RT

end-effector robot-assisted training

Group Type: EXPERIMENTAL

robot-assisted

Intervention Type: DEVICE

Participants received the 18-session robot-assisted intervention 3 sessions a week for 6 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.

conventional training groups

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation intervention

Intervention Type: DEVICE

Participants received the 18-session conventional rehabilitation intervention 3 sessions a week for 6 consecutive weeks. The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.

Interventions

robot-assisted

Participants received the 18-session robot-assisted intervention 3 sessions a week for 6 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.

Intervention Type: DEVICE

Conventional rehabilitation intervention

Participants received the 18-session conventional rehabilitation intervention 3 sessions a week for 6 consecutive weeks. The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memotial Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

#886-3-2118800 ext. 5761

Facility Contacts

Ching-Yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

+886-3-2118800 ext. 5761

Other Identifiers

202101742B0

Identifier Type: -

Identifier Source: org_study_id