NCT03624153

The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients

The Effects of the EMG-driven Exoskeleton Hand Robotic Training Device on Upper Extremity Motor and Physiological Function, Daily Functions, Quality of Life and Self-efficacy in Brain Injury Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the effects of the EMG-driven exoskeleton hand robotic training device on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in brain injury patients.

Detailed description

The purpose of this study was to 1) examine the effects of EMG-driven robot-assisted intervention, and 2) examine whether the robot-assisted therapy is as effective as conventional intervention. The study was conducted using a randomized, two-period crossover design. Participants were randomly assigned to group 1 or group 2 using a computer-generated list. Participants in group 1 received 12 sessions of robot-assisted intervention first, followed by a one-month washout period, and then received 12 sessions of conventional intervention. Participants in group 2 received 12 sessions of conventional intervention first, followed by a one-month washout period, and then received 12 sessions of robot-assisted intervention. Outcome measures were performed before the intervention, after the first 12-session intervention, and after the second 12-session intervention.

Conditions

• Chronic Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Robotic-assisted intervention	Participants received the 12-session robot-assisted intervention 3 sessions a week for 4 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.
BEHAVIORAL	Conventional rehabilitation intervention	Participants received the 12-session conventional rehabilitation intervention 3 sessions a week for 4 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.

Timeline

• Start date: 2018-07-30
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-08-09
• Last updated: 2021-05-17

Locations

1 site across 1 country: Taiwan