Correlation Physiological Cost Index (CPCI)

Cardenal Herrera University

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Control group (GT); Other: Experimental group (GTVR)

Study type: Interventional

Funder types: Other

Identifiers

NCT03700073

2018-correlPCI

Details and patient eligibility

About

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.

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Walk training plus virtual reality

Experimental group

Description:

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

Treatment:

Other: Experimental group (GTVR)

Walk training

Active Comparator group

Description:

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

Treatment:

Other: Control group (GT)