Clinical trial NCT03624153: The Effects of Exoskeleton Robotic Training Device on Upper Extremity in Brain Injury Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change scores of Fugl-Myer Assessment (FMA)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Action Research Arm Test (ARAT)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
Secondary outcomes:
measure: Change scores of Mini-Mental State Exam (MMSE)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Jamar hand dynamometer
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of stroke self-efficacy questionnaire (SSEQ)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Modified Ashworth Scale (MAS)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
measure: Change scores of Active Range of Motion (AROM)
timeFrame: Baseline, after completing the first 12-session intervention sessions (around 4 weeks after baseline); after completing the second 12-session intervention sessions (around 12 weeks after baseline
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Ching-Yi Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YW, Chiang WC, Chang CL, Lo SM, Wu CY. Comparative effects of EMG-driven robot-assisted therapy versus task-oriented training on motor and daily function in patients with stroke: a randomized cross-over trial. J Neuroeng Rehabil. 2022 Jan 16;19(1):6. doi: 10.1186/s12984-021-00961-w.