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OpenTrials
Completed

NCT Number: NCT03700073

Correlation Physiological Cost Index

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica de Fisioterapia Maite Montañana

Valencia, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline Physiological cost index at 6 months

    Time frame: The test will be performed 6 month interval

    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 .

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Acronym: CPCI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2018
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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