Correlation Physiological Cost Index

NCT ID: NCT03700073

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-01-31

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.

Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Experimental group (GTVR)

Intervention Type OTHER

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

Walk training

Control group (GT): The intervention consisted of treatment with the robotic CL1Walker gait training system

Group Type ACTIVE_COMPARATOR

Control group (GT)

Intervention Type OTHER

Gait training with a robotic system (CL1Walker) alone.

Interventions

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Experimental group (GTVR)

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

Intervention Type OTHER

Control group (GT)

Gait training with a robotic system (CL1Walker) alone.

Intervention Type OTHER

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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardenal Herrera University

OTHER

Sponsor Role lead

Responsible Party

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Eva Segura Ortí

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva SEGURA-ORTÍ, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad CEU Cardenal Herrera, UCH CEU

Locations

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Clínica de Fisioterapia Maite Montañana

Valencia, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2018-correlPCI

Identifier Type: -

Identifier Source: org_study_id

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