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

22 mei 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Peru
    • Arequipa
      • Arequipa, Arequipa, Peru, 54

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Toestel Haalbaarheid
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Feseability and User Satisfaction
Participant will use Rehametrics plataform for training balance and gait
Apparaat: 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 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

Andere namen:
  • Rehametrics

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of eligible participants who complete all scheduled sessions
Tijdsspanne: Immediately after the intervention.
This will assess the feasibility of the intervention.
Immediately after the intervention.
User Satisfaction Evaluation Questionnaire (USEQ)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Functional Mobility - Timed Up and Go (TUG)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Nacional de San Agustin de Arequipa

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

21 november 2026

Studie voltooiing (Geschat)

21 november 2026

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

22 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PI_27_2024_UNSA
  • PI_27_2024 (Andere identificatie: Universidad Nacional de San Agustin de Arequipa)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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