NCT03700073

Correlation Physiological Cost Index

Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Cardenal Herrera University · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Design: Longitudinal, prospective, double blind study with two treatment groups and repeated measurements, controlled for the condition without virtual reality.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
OTHER	Experimental group (GTVR)	Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program
OTHER	Control group (GT)	Gait training with a robotic system (CL1Walker) alone.

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-10-09
• Last updated: 2019-02-27

Locations

1 site across 1 country: Spain