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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic-assisted intervention

70 minutes Robotic-assisted intervention.

Group Type EXPERIMENTAL

Robotic-assisted intervention

Intervention Type BEHAVIORAL

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.

Conventional intervention

70 minutes conventional rehabilitation.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. unilateral stroke ≥ 3 months prior to study enrollment
2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score \<60
3. without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3)
4. Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment
5. between the ages of 20 and 75 years.

Exclusion Criteria

1. histories of other neurological diseases such as dementia and peripheral polyneuropathy
2. difficulties in following and understanding instructions such as global aphasia
3. enroll in other rehabilitation or drug studies simultaneously
4. receiving Botulinum toxin injections within 3 months.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No