Correlation Physiological Cost Index

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03700073

Acronym

CPCI

Enrollment

Registered

2018-10-09

Start date

2018-11-01

Completion date

2019-01-31

Last updated

2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

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

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.

Detailed description

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

Interventions

OTHERExperimental group (GTVR)

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

OTHERControl group (GT)

Gait training with a robotic system (CL1Walker) alone.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline Physiological cost index at 6 months	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 .

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026