Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study

Abstract

Background: Even if clinical evidence on effectiveness is still lacking, innovative technological solutions like robotic gait training technologies are gaining increasing attention in pediatric neuromotor rehabilitation. Aim: This study aims to provide clinical-technological analysis for pediatric rehabilitation centers, build a rationale for driving future ideal rehabilitative pathways, and identify the most relevant criteria to evaluate robotic rehabilitation of the gait. Design: Pre-post test design. Setting: The robotic device comprises a bilaterally driven gait orthosis, computer-controlled guidance, and a non-immersive virtual reality system. Robotic-assisted locomotor treadmill therapy (RAGT) training was customized regarding training onset, duration, and specific gait parameters. Population: We assessed 47 patients (mean age: 9.6 years, SD: 3.8 years; 23 females) with several neurologic diseases subjected to RAGT and patient-centered therapy (i.e., traditional therapy). Methods: Inpatients were assessed in motor control, gait, cognition, and autonomies. The clinical investigation was integrated with a Health Technology Assessment (HTA) study, to investigate the introduction and impact of RAGT compared to patient-centered rehabilitation techniques and identify the most relevant criteria to assess the use of robotic rehabilitation technologies. Results: The Patient-centered vs. Hybrid (RAGT+patient-centered) group showed a statistically significant difference between pre-treatment and post-treatment in Gross Motor Function Classification System (GMFM) total mean score (p=0.02). A significant increase in the distance walked in 6 minutes was found in the comparison between pre and post-treatment evaluation in the hybrid group: average pre-post 126 vs. 156 meters (t(13) = 2.78: p<0.01). Conclusions: The HTA process provided the weights of each evaluation element described in the decision tree. Safety is considered the most important domain, followed by Ethical Aspects and Clinical Effectiveness, which reached about the same weight as the technical characteristics. Less importance was given to organizational aspects and costs.

Keywords

• neurological disease
• cerebral lesion
• paediatric
• robotic rehabilitation
• hta