A Randomized Controlled Trial on Improvement of Walking Ability in Stroke Patients Using a Kinetic Exoskeletal Orthosis

Research Objectives: To investigate the therapeutic effects of Kickstart wearable exoskeletal device on the walking ability of stroke patients

Design: Thirty in-patient stroke subjects were randomly assigned to the Control and Observational groups for a 4-week study to compare effects of Kickstart exoskeleton device vs. no assistive device during walking recovery

Setting: Shanghai Sunshine Rehabilitation Center is a leading comprehensive rehabilitation institution in Shanghai, China

Participants: Thirty patients with hemiplegia after stroke were selected and divided into the Control and Observational groups by random number table

Interventions: Subjects in both groups received routine PT training at the hospital's rehabilitation facility each for five sessions per week. After the routine training, the Control group underwent walking training without assisted devices but the Observational group wore a Kickstart exoskeletal device during walking exercise, each for no less than 1 hour a day, five days/week for 4 weeks.

Main Outcome Measures: (1) the 10-m walking test; (2) the Timed Up and Go test; (3) the 6-minute walking test; (4) 3-D spatiotemporal gait analysis

Results: Before and after intervention, there were significant differences in TUGT (P < 0.01), 10MWT (P < 0.01) and 6MWT (P < 0.01), walking speed (P < 0.05), stride length (P < 0.05) and non-affected side step length (P < 0.05) in the Observational group. In comparison, there were significant differences in TUGT (P < 0.01), 6MWT (P < 0.01) and 10MWT (P < 0.05) in the Control group. Between groups, there were significant differences in TUGT (-8.67 ±8.02s, Observational vs. -3.46±3.59s, Control; P < 0.05) and 6MWT (7.62 + / - 8.31s, Observational vs. -5.01±8.88s, Control; P < 0.05) before and after interventions during the 4-week period.

Conclusions: These findings demonstrated that the Kickstart exoskeletal device had a positive effect in improving walking ability in stroke survivors. In addition, the exoskeletal device could be integrated into current therapeutic programs to enhance walking recovery for stroke patients.

Author(s) Disclosures: Real Star Rehabilitation Equipment Co., Ltd. supplied the Kickstart walk assist device used in this study.