Correlation Physiological Cost Index

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

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Experimental group (GTVR)
* Other: Control group (GT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walk training plus virtual reality<br>Experimental group (GTVR): The intervention consisted of treatment with the robotic CL1Walker gait training system in combination with virtual reality | Other: Experimental group (GTVR)<br>* Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program<br>|
| Active Comparator: Walk training<br>Control group (GT): The intervention consisted of treatment with the robotic CL1Walker gait training system | Other: Control group (GT)<br>* Gait training with a robotic system (CL1Walker) alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 . | The test will be performed 6 month interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health-related quality of life, gait deviation index, cerebral palsy, gait analysis, physiological cost index