Clinical study on the safety and feasibility of AiWalker-K for lower limbs exercise rehabilitation in children with cerebral palsy

PLoS One. 2024 May 22;19(5):e0303517. doi: 10.1371/journal.pone.0303517. eCollection 2024.

Abstract

Background: Robotic-assisted gait training (RAGT) devices are effective for children with cerebral palsy (CP). Many RAGT devices have been created and put into clinical rehabilitation treatment. Therefore, we aimed to investigate the safety and feasibility of a new RAGT for children with CP.

Methods: This study is a cross-over design with 23 subjects randomly divided into two groups. The occurrence of adverse events and changes in heart rate and blood pressure were recorded during each AiWalker-K training. Additionally, Gross Motor Function Measure-88 (GMFM-88), Pediatric Balance Scale (PBS), 6 Minutes Walking Test (6MWT), Physiological Cost Index, and Edinburgh Visual Gait Score (EVGS) were used to assess treatment, period, carry-over, and follow-up effects in this study.

Results: Adverse events included joint pain, skin pain, and injury. Heart rate and blood pressure were higher with the AiWalker-K compared to the rest (P < 0.05), but remained within safe ranges. After combined treatment with AiWalker-K and routine rehabilitation treatment, significant improvements in 6MWT, GMFM-88 D and E, PBS, and EVGS were observed compared to routine rehabilitation treatment alone (P < 0.05).

Conclusions: Under the guidance of experienced medical personnel, AiWalker-K can be used for rehabilitation in children with CP.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Blood Pressure
  • Cerebral Palsy* / physiopathology
  • Cerebral Palsy* / rehabilitation
  • Child
  • Cross-Over Studies
  • Exercise Therapy* / methods
  • Feasibility Studies*
  • Female
  • Gait / physiology
  • Heart Rate
  • Humans
  • Lower Extremity* / physiopathology
  • Male
  • Robotics / instrumentation
  • Robotics / methods

Grants and funding

This study was funded by the construction of precise rehabilitation management platform for disabled children based on cloud services, key research and development and promotion special project (technology breakthrough) in Henan Province in 2023, 2023.1-2024.12, project number: 232102310135. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.