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Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy (Rehametrics-CP)

22 de maio de 2026 atualizado por: Elizabeth Vidal, Universidad Nacional de San Agustin de Arequipa

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

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

Visão geral do estudo

Status

Ainda não está recrutando

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

10

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

    • Arequipa
      • Arequipa, Arequipa, Peru, 54
        • Pedro P. Diaz
        • Contato:
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Viabilidade do dispositivo
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Feseability and User Satisfaction
Participant will use Rehametrics plataform for training balance and gait

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 clinicians to objectively monitor patient evolution over time.

To date, however, no published study has evaluated the Rehametrics system specifically in children with CP. Given the platform's CE medical device certification, its non-immersive, contact-free interaction mode, its capacity for progressive difficulty adaptation, particularly relevant for pediatric patients, and its ability to quantify motor performance objectively during sessions, it represents a clinically appropriate and technically

Outros nomes:
  • Rehametrics

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of eligible participants who complete all scheduled sessions
Prazo: Immediately after the intervention.
This will assess the feasibility of the intervention.
Immediately after the intervention.
User Satisfaction Evaluation Questionnaire (USEQ)
Prazo: Immediately after the intervention
The User Satisfaction Evaluation Questionnaire for Virtual Rehabilitation Systems (USEQ) is a 6-item instrument developed specifically for virtual rehabilitation contexts (Gil-Gomez et al., 2017). Items are rated on a 5-point Likert scale and evaluate: (1) ease of system use; (2) level of enjoyment during interaction; (3) interface clarity; (4) perceived usefulness; (5) degree of control during task execution; (6) willingness to use the system again. The USEQ will be administered to participants (or parents/guardians as proxy for younger children) and to the supervising physiotherapist at the end of the intervention period.
Immediately after the intervention

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functional Mobility - Timed Up and Go (TUG)
Prazo: Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)
The TUG test measures functional mobility and dynamic balance. The participant rises from a standard chair, walks 3 meters, turns, returns to the chair, and sits. Time is recorded in seconds. Reliability and validity have been established for children with CP
Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)
Gross Motor Function - GMFM-88
Prazo: Baseline, pre-intervention and immediately after the intervention
The Gross Motor Function Measure (GMFM-88) is a standardized, validated clinical observational instrument developed to evaluate gross motor function in children with CP (Russell et al., 2000, 2002). It comprises 88 items scored on a 4-point ordinal scale (0 = does not initiate, 1 = initiates task <10%, 2 = partially completes task 10-99%, 3 = completes task 100%; NT = not tested). Items are grouped into five dimensions: (A) Lying and Rolling, (B) Sitting, (C) Crawling and Kneeling, (D) Standing, (E) Walking, Running and Jumping. Dimension scores are expressed as percentages of the maximum possible score, and the total score is the mean of the five dimension percentages.
Baseline, pre-intervention and immediately after the intervention
Balance - Pediatric Balance Scale (PBS)
Prazo: Baseline, pre-intervention, and immediately after the intervention
The Pediatric Balance Scale (PBS) is an adaptation of the Berg Balance Scale specifically designed to evaluate static and dynamic balance in children with neurological, musculoskeletal, or developmental conditions (Chia-ling et al., 2013). It comprises 14 functional tasks, each scored 0 to 4 (0 = unable to perform; 4 = performs independently and correctly). Tasks include: sit-to-stand, stand-to-sit, transfers, standing steady, feet-together standing, forward reach with extended arm, floor object retrieval from standing, turning to look behind, 360-degree turn, tandem standing, single-leg stance, single-leg balance, single-leg hopping, and standing on a soft surface.
Baseline, pre-intervention, and immediately after the intervention
Participation - Pittsburgh Rehabilitation Participation Scale (PRPS)
Prazo: immediately after the procedure (end-of-session rating by the physiotherapist).
The PRPS is a 6-point clinician-rated scale measuring active patient participation during rehabilitation sessions (Lenze et al., 2004). Ratings: 1 = no participation in any session; 2 = no participation in at least half of sessions; 3 = participation in most exercises without maximum effort or incomplete; 4 = good participation in all exercises with good effort, most completed; 5 = very good participation with maximum effort, all completed; 6 = excellent participation with maximum effort, all completed, and active interest shown. The physical therapist will complete the PRPS at the end of each session.
immediately after the procedure (end-of-session rating by the physiotherapist).
User Experience Questionnaire - UEQ
Prazo: Immediately after the Intervention
The User Experience Questionnaire description (UEQ) is a standardized instrument that evaluates six dimensions: (1) attractiveness, (2) efficiency, (3) perspicuity, (4) dependability, (5) stimulation, and (6) novelty. The UEQ comprises 26 items, rated on a 7-point Likert scale. The UEQ analyzes user experience results on a scale from -3 to +3, interpreted by ranges: 1.5 to 3.0 as very positive or excellent, 0.5 to 1.5 as positive or good, -0.5 to 0.5 as neutral, -1.5 to -0.5 as negative or low, and below -1.5 as very negative or poor. These ranges allow a quick assessment of the user's perception of the system
Immediately after the Intervention
Rehametrics performance scores
Prazo: Immediately after the procedure (session 1-9).
At each session, the Rehametrics software automatically records and exports session-level kinematic performance data for each participant. These parameters include joint range of motion, base of support, displacement of the center of gravity, and step height and characteristics. Additionally, the system records exercise completion scores (proportion of tasks successfully completed per session), total active movement time, and difficulty level reached per exercise. These data will be extracted from the system's automatic clinical reports at the end of each session and compiled longitudinally to track intra-subject performance evolution across the 9 sessions.
Immediately after the procedure (session 1-9).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Emilia Biffi, Phd, Scientific Institute IRCCS E. Medea

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

21 de novembro de 2026

Conclusão do estudo (Estimado)

21 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

14 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • PI_27_2024_UNSA
  • PI_27_2024 (Outro identificador: Universidad Nacional de San Agustin de Arequipa)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Participant data will be stored using pseudonymized codes rather than names, preventing identification by persons outside the research team. No information that permits the identification of individual participants will be disclosed in any publication or presentation. All documents containing participant information will be stored in a locked cabinet in a restricted-access area. Digital data will be stored on password-protected systems accessible only to authorized study personnel. Personal identifiers and study codes will be stored in separate, locked locations.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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