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

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...

Full description

Saved in:
Bibliographic Details
Main Authors: Simone GAZZELLINI, Martina ANDELLINI, Federica DE FALCO, Daniela CASASANTA, Giampietro CORDONE, Alessandra COLAZZA, Donatella LETTORI, Massimiliano RAPONI, Enrico CASTELLI, Maria Rosaria VINCI, Reparata Rosa DI PRINZIO, Maurizio PETRARCA, Matteo RITROVATO, Salvatore ZAFFINA
Format: Article
Language:English
Published: Edizioni FS 2023-03-01
Series:Journal of Health and Social Sciences
Subjects:
Online Access:https://journalhss.com/wp-content/uploads/Gazzellini-et-al-JHSS-76-92.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1832595578465288192
author Simone GAZZELLINI
Martina ANDELLINI
Federica DE FALCO
Daniela CASASANTA
Giampietro CORDONE
Alessandra COLAZZA
Donatella LETTORI
Massimiliano RAPONI
Enrico CASTELLI
Maria Rosaria VINCI
Reparata Rosa DI PRINZIO
Maurizio PETRARCA
Matteo RITROVATO
Salvatore ZAFFINA
author_facet Simone GAZZELLINI
Martina ANDELLINI
Federica DE FALCO
Daniela CASASANTA
Giampietro CORDONE
Alessandra COLAZZA
Donatella LETTORI
Massimiliano RAPONI
Enrico CASTELLI
Maria Rosaria VINCI
Reparata Rosa DI PRINZIO
Maurizio PETRARCA
Matteo RITROVATO
Salvatore ZAFFINA
author_sort Simone GAZZELLINI
collection DOAJ
description 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.
format Article
id doaj-art-e08bce272c2b41159a85d1de6a1bf47a
institution Kabale University
issn 2499-2240
language English
publishDate 2023-03-01
publisher Edizioni FS
record_format Article
series Journal of Health and Social Sciences
spelling doaj-art-e08bce272c2b41159a85d1de6a1bf47a2025-01-18T18:20:30ZengEdizioni FSJournal of Health and Social Sciences2499-22402023-03-0181769210.19204/2023/clnc6Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental studySimone GAZZELLINIMartina ANDELLINIFederica DE FALCODaniela CASASANTAGiampietro CORDONEAlessandra COLAZZADonatella LETTORIMassimiliano RAPONIEnrico CASTELLIMaria Rosaria VINCIReparata Rosa DI PRINZIOMaurizio PETRARCAMatteo RITROVATOSalvatore ZAFFINABackground: 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.https://journalhss.com/wp-content/uploads/Gazzellini-et-al-JHSS-76-92.pdfneurological diseasecerebral lesionpaediatricrobotic rehabilitationhta
spellingShingle Simone GAZZELLINI
Martina ANDELLINI
Federica DE FALCO
Daniela CASASANTA
Giampietro CORDONE
Alessandra COLAZZA
Donatella LETTORI
Massimiliano RAPONI
Enrico CASTELLI
Maria Rosaria VINCI
Reparata Rosa DI PRINZIO
Maurizio PETRARCA
Matteo RITROVATO
Salvatore ZAFFINA
Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
Journal of Health and Social Sciences
neurological disease
cerebral lesion
paediatric
robotic rehabilitation
hta
title Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
title_full Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
title_fullStr Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
title_full_unstemmed Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
title_short Clinical study and Health Technology Assessment (HTA) of a Robot-Assisted Gait Training on children with neurological disorders: A quasi-experimental study
title_sort clinical study and health technology assessment hta of a robot assisted gait training on children with neurological disorders a quasi experimental study
topic neurological disease
cerebral lesion
paediatric
robotic rehabilitation
hta
url https://journalhss.com/wp-content/uploads/Gazzellini-et-al-JHSS-76-92.pdf
work_keys_str_mv AT simonegazzellini clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT martinaandellini clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT federicadefalco clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT danielacasasanta clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT giampietrocordone clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT alessandracolazza clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT donatellalettori clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT massimilianoraponi clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT enricocastelli clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT mariarosariavinci clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT reparatarosadiprinzio clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT mauriziopetrarca clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT matteoritrovato clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy
AT salvatorezaffina clinicalstudyandhealthtechnologyassessmenthtaofarobotassistedgaittrainingonchildrenwithneurologicaldisordersaquasiexperimentalstudy