Correlation Physiological Cost Index

Cerebral Palsy Clinical Trial

— CPCI  

Official title:

Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700073
• Other study ID #: 2018-correlPCI
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: February 2019
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Experimental group (GTVR)
Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program
• Control group (GT)
Gait training with a robotic system (CL1Walker) alone.

Locations

Country	Name	City	State
Spain	Clínica de Fisioterapia Maite Montañana	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 .	The test will be performed 6 month interval