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.|
|ClinicalTrials.gov Identifier: NCT03700073|
Recruitment Status : Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 15, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- 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 .
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 ClinicalTrials.gov identifier (NCT number): NCT03700073
|Contact: Javier Martinez-Gramage, PhD||00 34 9613369000 ext firstname.lastname@example.org|
|Principal Investigator:||Eva SEGURA-ORTÍ, PhD||Universidad CEU Cardenal Herrera, UCH CEU|