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Correlation Physiological Cost Index (CPCI)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Experimental group (GTVR)
Control group (GT)
Sponsored by
Cardenal Herrera University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring physiological cost index, health-related quality of life, gait deviation index, gait analysis, cerebral palsy

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clínica de Fisioterapia Maite Montañana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Walk training plus virtual reality

Walk training

Arm Description

Experimental group (GTVR): The intervention consisted of treatment with the robotic CL1Walker gait training system in combination with virtual reality

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
July 12, 2018
Last Updated
February 26, 2019
Sponsor
Cardenal Herrera University
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1. Study Identification

Unique Protocol Identification Number
NCT03700073
Brief Title
Correlation Physiological Cost Index
Acronym
CPCI
Official Title
Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
physiological cost index, health-related quality of life, gait deviation index, gait analysis, cerebral palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Walk training plus virtual reality
Arm Type
Experimental
Arm Description
Experimental group (GTVR): The intervention consisted of treatment with the robotic CL1Walker gait training system in combination with virtual reality
Arm Title
Walk training
Arm Type
Active Comparator
Arm Description
Control group (GT): The intervention consisted of treatment with the robotic CL1Walker gait training system
Intervention Type
Other
Intervention Name(s)
Experimental group (GTVR)
Intervention Description
Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program
Intervention Type
Other
Intervention Name(s)
Control group (GT)
Intervention Description
Gait training with a robotic system (CL1Walker) alone.
Primary Outcome Measure Information:
Title
Change from baseline Physiological cost index at 6 months
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva SEGURA-ORTÍ, PhD
Organizational Affiliation
Universidad CEU Cardenal Herrera, UCH CEU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica de Fisioterapia Maite Montañana
City
Valencia
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Correlation Physiological Cost Index

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