2. Methods
spasticity, ’, stroke, upper limb hemiparesis, upper extremity peripheral nervous system disease, contracture, fracture, upper extremity musculoskeletal problems, pain, cognitive decline, upper limb spasticity
STROKE, EVENT, SECONDARY
The study design was a single-center, prospective, non-blinded, randomized controlled trial (KCT0006808). The study was approved by the Asan Medical Center Institutional Review Board (no. 2021-0643). Written informed consents were given for all participants.The inclusion criteria were as follows: patients with upper limb hemiparesis after 12 months of the stroke event, age > 19 upper limb spasticity grade lower <3, and Brunnstrom recovery stages of IV, V, and VI. Exclusion criteria were as follows: patients with the severe cognitive decline with lack of communication, upper extremity musculoskeletal problems, combined upper extremity peripheral nervous system disease, badly progressed upper limb contracture, those with comorbidities who cannot perform upper limb rehabilitation, those involved in other studies, and those a high risk of fracture.Participants recruited were followed up at the rehabilitation department of the outpatient clinic. The randomization sequence was contrived using Excel 2016 (Microsoft, WA) to allocate patients randomly to the HEXO or control group. All participants underwent a 30-minute physical therapy session 10 times in total in 3 weeks. The HEXO group physical therapy included upper limb exercises provided by Hexo-UR30A. Each program included 5 minutes of warm-up, 5 minutes of cool-down in each, and 20 minutes of main training with Hexo-UR30A including shoulder flexion-extension, abduction-adduction, and internal rotation-external rotation exercise. The angular velocity was 10 degrees for 60 seconds, and each degree to shoulder joint moved was optimized to the maximum extent patients can move and do not feel pain or discomfort. In the control group, patients were instructed to perform upper limb range of motion exercise with an ergometer for 30 minutes. The functional and neurologic parameters were evaluated prior to the start of the treatment (baseline) and after the 3-week training session (post-treatment).The primary evaluation includes upper limb motor function, assessed using Fugl–Meyer Assessment for the upper extremity and Motricity Index for the upper extremity. The Fugl–Meyer Assessment is one of the most recommended motor function assessments in clinical trials for stroke patients’ rehabilitation.The secondary evaluation includes the Modified Barthel Index, active range of motion, passive range of motion, spasticity measured using the modified Ashworth scale (MAS) grade, and patients’ satisfaction. Modified Barthel Index evaluated the activity of daily living (ADL) of patients, including personal hygiene and feeding, from 0 points (totally dependent) to 100 (independent).Satisfaction questionnaire.An appropriate sample size based on power analysis was not calculated since the study was designed as a pilot study. Statistical analyses were performed using SPSS statistics version 18.0 (SPSS Inc, Chicago, IL). The characteristics of patients were analyzed using Student 