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

Chang Gung Medical Foundation

Status: Completed

Conditions: Chronic Stroke

Treatments: Behavioral: Conventional rehabilitation intervention; Behavioral: Robotic-assisted intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03624153

201701543B0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

31 participants in 2 patient groups

Robotic-assisted intervention

Experimental group

Description:

70 minutes Robotic-assisted intervention.

Treatment:

Behavioral: Robotic-assisted intervention

Conventional intervention

Active Comparator group

Description:

70 minutes conventional rehabilitation.

Treatment:

Behavioral: Conventional rehabilitation intervention