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Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy
Objective: To compare the efficacy of a gait training program using robotic assistance combined with virtual reality versus robotic assistance alone on energy expenditure in children with cerebral palsy. Participants: Children with cerebral palsy levels II, III, IV, and V according to the Gross Motor Function Classification System (GMFCS), from different paediatric physiotherapy centres and schools in Valencia, Spain. Intervention: Gait training using an inexpensive robotic gait training system (CL1Walker) and participation in a virtual reality game, Treasure Hunt (abbreviated here as ACT, from the Spanish A la Caza del Tesoro) in the experimental group (GTVR) and gait training using the same robotic gait training system without using virtual reality in the control group (GT). Measurements: Assessment using the Physiological Cost Index (PCI) one week prior to and after the intervention. The intraclass correlation (ICC) replicability and the minimum detectable change (MDC) of the PCI.
Design: Longitudinal, prospective, double blind study with two treatment groups and repeated measurements, controlled for the condition without virtual reality.
Age
5 - 16 years
Sex
ALL
Healthy Volunteers
No
Clínica de Fisioterapia Maite Montañana
Valencia, Spain
Start Date
November 1, 2018
Primary Completion Date
January 31, 2019
Completion Date
January 31, 2019
Last Updated
February 27, 2019
26
ACTUAL participants
Experimental group (GTVR)
OTHER
Control group (GT)
OTHER
Lead Sponsor
Cardenal Herrera University
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07168577