Correlation Physiological Cost Index

NCT03700073 | Completed

• 1 other identifier: 2018-correlPCI
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

physiological cost index; health-related quality of life; gait deviation index; gait analysis; cerebral palsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Walk training plus virtual reality

EXPERIMENTAL

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

Other: Experimental group (GTVR)

Walk training

ACTIVE COMPARATOR

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

Other: Control group (GT)

Interventions

Experimental group (GTVR) OTHER

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

Walk training plus virtual reality

Control group (GT) OTHER

Gait training with a robotic system (CL1Walker) alone.

Walk training

Eligibility Criteria

• Age: 5 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of cerebral palsy
• Must be able to follow the instructions and participate in the game

You may not qualify if:

• Orthopaedic surgery in lower limb
• Botulinum toxin in lower limb

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Clínica de Fisioterapia Maite Montañana

Valencia, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Eva SEGURA-ORTÍ, PhD

  Universidad CEU Cardenal Herrera, UCH CEU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: October 9, 2018
• Study Start: November 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: February 27, 2019

Record last verified: 2019-02

Locations

ES (1)