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Correlation Physiological Cost Index (CPCI)
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) |
| Actual Enrollment : | 26 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Correlation Between Physiological Cost Index and Health-related Quality of Life in Cerebral Palsy |
| Actual Study Start Date : | November 1, 2018 |
| Actual Primary Completion Date : | January 31, 2019 |
| Actual Study Completion Date : | January 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
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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
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Other: Experimental group (GTVR)
Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program
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Active Comparator: Walk training
Control group (GT): The intervention consisted of treatment with the robotic CL1Walker gait training system
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Other: Control group (GT)
Gait training with a robotic system (CL1Walker) alone.
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- 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 .
| Ages Eligible for Study: | 5 Years to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Spain | |
| Clínica de Fisioterapia Maite Montañana | |
| Valencia, Spain | |
| Principal Investigator: | Eva SEGURA-ORTÍ, PhD | Universidad CEU Cardenal Herrera, UCH CEU |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 12, 2018 | ||||
| First Posted Date ICMJE | October 9, 2018 | ||||
| Last Update Posted Date | February 27, 2019 | ||||
| Actual Study Start Date ICMJE | November 1, 2018 | ||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 .
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| Original Primary Outcome Measures ICMJE |
Change from baseline Physiological cost index at 6 months [ Time Frame: The test will be performed 6 month interval ] Index of gait efficiency
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE |
Change from baseline Pediatric quality of life inventory at 6 months [ Time Frame: The questionnaire will be answered 6 month interval ] Children adapted health-related quality of life
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Correlation Physiological Cost Index | ||||
| Official Title ICMJE | Correlation Between Physiological Cost Index and Health-related Quality of Life in 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. |
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| Detailed Description | Design: Longitudinal, prospective, double blind study with two treatment groups and repeated measurements, controlled for the condition without virtual reality. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Cerebral Palsy | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
26 | ||||
| Original Estimated Enrollment ICMJE |
30 | ||||
| Actual Study Completion Date ICMJE | January 31, 2019 | ||||
| Actual Primary Completion Date | January 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 5 Years to 16 Years (Child) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Spain | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03700073 | ||||
| Other Study ID Numbers ICMJE | 2018-correlPCI | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Eva Segura Ortí, Cardenal Herrera University | ||||
| Study Sponsor ICMJE | Cardenal Herrera University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Cardenal Herrera University | ||||
| Verification Date | February 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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