Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy

Official title

Non-Immersive Virtual Reality for Gait and Balance Training With Rehametrics in Children With Cerebral Palsy: Protocol for a Pre-post Single Group Pilot Study

Overview

The goal of this clinical trial is to evaluate the feasibility and user satisfaction of a non-immersive VR rehabilitation system, i.e. Rehametrics, for gait and balance training in children with CP in children between 4 to 10 years old. Secondary objectives include assessing the system's impact on functional mobility, gross motor function, balance, active participation, and user experience. Primary hypothesis: rehabilitation intervention with Rehametrics is feasible and well accepted in a clinical setting for children with CP aged 4 to 10 years. Participants will train exercises related to balance and gait using Rehametrics platform

Detailed description

Background Cerebral palsy (CP) is the most common motor disability in childhood, affecting movement, muscle tone, and posture as a result of a non-progressive lesion in the developing brain. Children with CP frequently present with alterations in gait and postural control that significantly impact their daily functioning and quality of life. Although conventional physical therapy remains the cornerstone of rehabilitation, adherence and motivation are persistent challenges, particularly in pediatric populations. Non-immersive virtual reality (VR) systems, such as Rehametrics, which use standard screens and motion-capture sensors rather than head-mounted displays, offer an interactive, game-based rehabilitation environment that may enhance motivation, promote repetitive motor practice, and provide objective performance metrics to clinicians.

Objective The primary aim of this study is to evaluate the feasibility and user satisfaction of a non-immersive VR rehabilitation system, i.e. Rehametrics, for gait and balance training in children with CP. Secondary objectives include assessing the system's impact on functional mobility, gross motor function, balance, active participation, and user experience.

Methods This is a pre-post single group pilot exploratory study. Ten children aged 4 to 10 years with a diagnosis of CP, confirmed by a pediatric neurologist, will be recruited from Centro Médico Pedro P. Diaz, Arequipa, Peru. Each participant will serve as their own control. The intervention consists of 9 sessions with Rehametrics, a non-immersive VR rehabilitation system designed to train gait and balance through interactive virtual scenarios. Outcome measures include: number of sessions completed, the User Satisfaction Evaluation Questionnaire (USEQ), the Timed Up and Go test (TUG), the Gross Motor Function Measure (GMFM-88), the Pediatric Balance Scale (PBS), the Pittsburgh Rehabilitation Participation Scale (PRPS), and the User Experience Questionnaire (UEQ). Pre- and post-intervention assessments will be conducted by a trained physical therapist blinded to session performance data. Statistical analysis will use paired Student's t-test for normally distributed continuous variables and non-parametric tests (Wilcoxon signed-rank) for ordinal data.

Results Recruitment has not yet commenced. Results from this pilot study are expected to provide preliminary estimates of effect size and feasibility parameters to inform the design of a larger controlled trial.

Conclusions This protocol describes a novel application of Rehametrics, as a rehabilitation tool for children with CP. Findings will contribute evidence on the feasibility, satisfaction and preliminary clinical outcomes of game-based VR training targeting gait and balance in a pediatric rehabilitation setting in a middle income country context.

Interventions

• Device non inmersive VR System
  The Rehametrics® platform is a CE-certified non-immersive virtual rehabilitation software that operates via a Microsoft Kinect sensor to capture full-body movement without contact-based sensors. . It provides over 80 motor, cognitive, and occupational therapy exercises structured as gamified tasks, with automatic difficulty adaptation based on real-time patient performance and multimodal feedback (visual, auditory, and performance). The system generates quantitative session reports, enabling cli

Primary outcome measures

• Proportion of eligible participants who complete all scheduled sessions [Time frame: Immediately after the intervention.]
• User Satisfaction Evaluation Questionnaire (USEQ) [Time frame: Immediately after the intervention]

Secondary outcome measures (6)

• Functional Mobility - Timed Up and Go (TUG) [Time frame: Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)]
• Gross Motor Function - GMFM-88 [Time frame: Baseline, pre-intervention and immediately after the intervention]
• Balance - Pediatric Balance Scale (PBS) [Time frame: Baseline, pre-intervention, and immediately after the intervention]
• Participation - Pittsburgh Rehabilitation Participation Scale (PRPS) [Time frame: immediately after the procedure (end-of-session rating by the physiotherapist).]
• User Experience Questionnaire - UEQ [Time frame: Immediately after the Intervention]
• Rehametrics performance scores [Time frame: Immediately after the procedure (session 1-9).]

Eligibility criteria

Inclusion criteria

• Age between 4 and 10 years (inclusive) at the time of enrollment.
• Confirmed clinical diagnosis of cerebral palsy documented in the medical record by a pediatric neurologist.
• Gross Motor Function Classification System (GMFCS) level I, II, or III
• Ability to stand independently or with minimal assistance for at least 30 seconds.
• Capacity to interact with a screen-based virtual environment (sufficient visual and cognitive ability to follow game instructions with therapist support).
• Written informed consent provided by parent or legal guardian.
• Availability to attend all scheduled sessions at the clinical site.

Exclusion criteria

• Severe or uncontrolled epilepsy that contraindicates interaction with visual stimuli (photosensitive epilepsy).
• Severe cognitive or behavioral impairment precluding participation in game-based VR interaction.
• Presence of acute musculoskeletal injuries or recent surgical interventions (within the preceding 3 months) affecting lower limb function.
• Participation in another rehabilitation research study during the study period.
• Visual impairment not correctable with glasses or lenses.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

Peru · 1 center

• Pedro P. Diaz — Arequipa

Publications

• Russell DJ, Avery LM, Rosenbaum PL, Raina PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Phys Ther. 2000 Sep;80(9):873-85. PMID 10960935
• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. PMID 17370477
• Ravi DK, Kumar N, Singhi P. Effectiveness of virtual reality rehabilitation for children and adolescents with cerebral palsy: an updated evidence-based systematic review. Physiotherapy. 2017 Sep;103(3):245-258. doi: 10.1016/j.physio.2016.08.004. Epub 2016 Sep 27. PMID 28109566
• Monge Pereira E, Molina Rueda F, Alguacil Diego IM, Cano de la Cuerda R, de Mauro A, Miangolarra Page JC; CONSOLIDER-Ingenio 2010. Use of virtual reality systems as proprioception method in cerebral palsy: clinical practice guideline. Neurologia. 2014 Nov-Dec;29(9):550-9. doi: 10.1016/j.nrl.2011.12.004. Epub 2012 Feb 17. English, Spanish. PMID 22341675
• Parsons TD, Gaggioli A, Riva G. Virtual Reality for Research in Social Neuroscience. Brain Sci. 2017 Apr 16;7(4):42. doi: 10.3390/brainsci7040042. PMID 28420150
• Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22. PMID 24958005
• Nossa R, Gagliardi C, Panzeri D, Diella E, Maghini C, Genova C, Turconi AC, Biffi E. Could an Immersive Virtual Reality Training Improve Navigation Skills in Children with Cerebral Palsy? A Pilot Controlled Study. J Clin Med. 2022 Oct 18;11(20):6146. doi: 10.3390/jcm11206146. PMID 36294467
• Nicolini-Panisson RD, Donadio MV. Timed "Up & Go" test in children and adolescents. Rev Paul Pediatr. 2013 Sep;31(3):377-83. doi: 10.1590/S0103-05822013000300016. PMID 24142322

Identifiers

NCT: NCT07612332 · PI_27_2024_UNSA · PI_27_2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗