Correlation Physiological Cost Index

Cardenal Herrera University26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Experimental group (GTVR)OTHER

Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program

Control group (GT)OTHER

Gait training with a robotic system (CL1Walker) alone.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of cerebral palsy * Must be able to follow the instructions and participate in the game Exclusion Criteria: * Orthopaedic surgery in lower limb * Botulinum toxin in lower limb

Locations (1)

Clínica de Fisioterapia Maite Montañana

Valencia, Spain

Outcomes

Primary Outcomes

Change from baseline Physiological cost index at 6 months

Index of gait efficiency trough Physiological Cost Index. It's a valuable indicator of gait efficiency in children with different Cerebral Palsy-related disability levels and it can predict their future level of societal activity and participation. To establish normal gait efficiency parameters, the Physiological Cost Index in children without disabilities is 0.4 with shoes and 0.38 barefoot .

Time frame: The test will be performed 6 month interval

Data from ClinicalTrials.gov

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