Trial record 69 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Correlation Physiological Cost Index (CPCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03700073
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
Eva Segura Ortí, Cardenal Herrera University

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: Experimental group (GTVR) Other: Control group (GT) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  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 .

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03700073

Contact: Javier Martinez-Gramage, PhD 00 34 9613369000 ext 65438

Sponsors and Collaborators
Cardenal Herrera University
Principal Investigator: Eva SEGURA-ORTÍ, PhD Universidad CEU Cardenal Herrera, UCH CEU

Responsible Party: Eva Segura Ortí, Professor, Cardenal Herrera University Identifier: NCT03700073     History of Changes
Other Study ID Numbers: 2018-correlPCI
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eva Segura Ortí, Cardenal Herrera University:
physiological cost index
health-related quality of life
gait deviation index
gait analysis
cerebral palsy

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases