Correlation Physiological Cost Index (CPCI)

February 26, 2019 updated by: Eva Segura Ortí, Cardenal Herrera University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain
        • Clínica de Fisioterapia Maite Montañana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

October 5, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 26, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-correlPCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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