- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07612332
Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy (Rehametrics-CP)
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Elizabeth Vidal, Phd
- Numero di telefono: +51986451412
- Email: evidald@unsa.edu.pe
Backup dei contatti dello studio
- Nome: Eveling Castro, Phd
- Numero di telefono: +51987 740 628
- Email: ecastro@unsa.edu.pe
Luoghi di studio
-
-
Arequipa
-
Arequipa, Arequipa, Perù, 54
- Pedro P. Diaz
-
Contatto:
- Elizabeth Vidal, Phd
- Numero di telefono: +51986451412
- Email: evidald@unsa.edu.pe
-
Contatto:
- Eveling Castro, Phd
- Numero di telefono: +51987740628
- Email: ecastro@unsa.edu.pe
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of eligible participants who complete all scheduled sessions
Lasso di tempo: Immediately after the intervention.
|
This will assess the feasibility of the intervention.
|
Immediately after the intervention.
|
|
User Satisfaction Evaluation Questionnaire (USEQ)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Functional Mobility - Timed Up and Go (TUG)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Emilia Biffi, Phd, Scientific Institute IRCCS E. Medea
Pubblicazioni e link utili
Pubblicazioni generali
- Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
- Carey H, Martin K, Combs-Miller S, Heathcock JC. Reliability and Responsiveness of the Timed Up and Go Test in Children With Cerebral Palsy. Pediatr Phys Ther. 2016 winter;28(4):401-8. doi: 10.1097/PEP.0000000000000301.
- 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.
- Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.
- Lenze EJ, Munin MC, Quear T, Dew MA, Rogers JC, Begley AE, Reynolds CF 3rd. The Pittsburgh Rehabilitation Participation Scale: reliability and validity of a clinician-rated measure of participation in acute rehabilitation. Arch Phys Med Rehabil. 2004 Mar;85(3):380-4. doi: 10.1016/j.apmr.2003.06.001.
- Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
- 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.
- Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.
- Bonnechere B, Jansen B, Omelina L, Van Sint Jan S. The use of commercial video games in rehabilitation: a systematic review. Int J Rehabil Res. 2016 Dec;39(4):277-290. doi: 10.1097/MRR.0000000000000190.
- Levac D, Missiuna C, Wishart L, Dematteo C, Wright V. Documenting the content of physical therapy for children with acquired brain injury: development and validation of the motor learning strategy rating instrument. Phys Ther. 2011 May;91(5):689-99. doi: 10.2522/ptj.20100415. Epub 2011 Mar 17.
- 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.
- 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.
- 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.
- Holden MK. Virtual environments for motor rehabilitation: review. Cyberpsychol Behav. 2005 Jun;8(3):187-211; discussion 212-9. doi: 10.1089/cpb.2005.8.187.
- Moreau NG, Bodkin AW, Bjornson K, Hobbs A, Soileau M, Lahasky K. Effectiveness of Rehabilitation Interventions to Improve Gait Speed in Children With Cerebral Palsy: Systematic Review and Meta-analysis. Phys Ther. 2016 Dec;96(12):1938-1954. doi: 10.2522/ptj.20150401. Epub 2016 Jun 16.
- 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.
- Gil-Gomez JA, Manzano-Hernandez P, Albiol-Perez S, Aula-Valero C, Gil-Gomez H, Lozano-Quilis JA. USEQ: A Short Questionnaire for Satisfaction Evaluation of Virtual Rehabilitation Systems. Sensors (Basel). 2017 Jul 7;17(7):1589. doi: 10.3390/s17071589.
- 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.
- 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.
- Lo HHM, Zhu M, Zou Z, Wong CL, Lo SHS, Chung VC, Wong SY, Sit RWS. Immersive and Nonimmersive Virtual Reality-Assisted Active Training in Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis. J Med Internet Res. 2024 Aug 19;26:e48787. doi: 10.2196/48787.
- Demont A, Gedda M, Lager C, de Lattre C, Gary Y, Keroulle E, Feuillerat B, Caudan H, Sancelme Z, Isapof A, Viehweger E, Chatelin M, Hochard M, Boivin J, Vurpillat P, Genes N, de Boissezon X, Fontaine A, Brochard S. Evidence-Based, Implementable Motor Rehabilitation Guidelines for Individuals With Cerebral Palsy. Neurology. 2022 Aug 16;99(7):283-297. doi: 10.1212/WNL.0000000000200936. Epub 2022 Jun 24.
- Coutts F. Gait analysis in the therapeutic environment. Man Ther. 1999 Feb;4(1):2-10. doi: 10.1016/s1356-689x(99)80003-4.
- Biffi E, Beretta E, Cesareo A, Maghini C, Turconi AC, Reni G, Strazzer S. An Immersive Virtual Reality Platform to Enhance Walking Ability of Children with Acquired Brain Injuries. Methods Inf Med. 2017 Mar 23;56(2):119-126. doi: 10.3414/ME16-02-0020. Epub 2017 Jan 24.
- AlSaif AA, Alsenany S. Effects of interactive games on motor performance in children with spastic cerebral palsy. J Phys Ther Sci. 2015 Jun;27(6):2001-3. doi: 10.1589/jpts.27.2001. Epub 2015 Jun 30.
- Novak I, Jackman M, Finch-Edmondson M, Fahey M. Cerebral palsy. Lancet. 2025 Jul 12;406(10499):174-188. doi: 10.1016/S0140-6736(25)00686-5. Epub 2025 Jun 20.
- Dan B, Rosenbaum P, Carr L, Gough M, Coughlan J, Nweke N. Proposed updated description of cerebral palsy. Dev Med Child Neurol. 2025 Jun;67(6):700-709. doi: 10.1111/dmcn.16274. Epub 2025 Apr 11.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PI_27_2024_UNSA
- PI_27_2024 (Altro identificatore: Universidad Nacional de San Agustin de Arequipa)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Paralisi cerebrale (PC)
-
Riphah International UniversityReclutamento
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Completato
-
Cairo UniversityAttivo, non reclutanteBilancia | Vibrazione di tutto il corpo | Terapia di rimbalzo | cpEgitto
-
Cairo UniversityReclutamentoBambini con emiplegico cp | Effetto degli esercizi pliometiciEgitto
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Erasmus Medical CenterTerminatoBCLC Stadio C HCC | Cirrosi epatica CP-BOlanda
-
Guang'anmen Hospital of China Academy of Chinese...Non ancora reclutamentoAgopuntura | Disfunzioni erettili | Prostatite cronica/Sindrome da dolore pelvico cronico (CP/CPPS)
-
Cairo UniversityReclutamentoMisure Antropometriche&Equilibrio IN CP BambiniEgitto
-
Joanne Kurtzberg, MDThe Robertson FoundationCompletatoParalisi cerebrale | Paralisi cerebrale spastica | CPStati Uniti
-
Cairo UniversityReclutamentoPCI (paralisi cerebrale) | Oro-motor | Mnri | Ome | Metodo MasgutovaEgitto
-
Ziauddin UniversityAttivo, non reclutanteParalisi cerebrale | Bilancia | CP | Qualità della vita (QOL)Pakistan
Prove cliniche su non inmersive VR System
-
University of Witten/HerdeckeFH Münster University of Applied Sciences; The Witten Institute For Family BusinessAttivo, non reclutanteFunzionamento psicologico e dei sistemiGermania
-
University of California, San FranciscoCompletatoDolore, Postoperatorio | Chirurgia | Realta virtuale | InvecchiatoStati Uniti
-
Prof. Dominique de Quervain, MDReclutamentoRespiro lentoSvizzera
-
Reciprocal LabsCalifornia HealthCare FoundationCompletato
-
Ahmed AbdullahCompletatoDolore, PostoperatorioPakistan
-
University of Maryland, BaltimoreReclutamentoDolore | Realta virtuale | Disturbo temporomandibolare | PlaceboStati Uniti
-
Cornell UniversityCompletatoSoglia del doloreStati Uniti
-
Reuth Rehabilitation Hospital6Degrees LTDNon ancora reclutamentoCVA (incidente cerebrovascolare) | Lesione cerebrale traumatica al trauma cranicoIsraele
-
University of California, DavisNational Institute of Mental Health (NIMH)Reclutamento
-
October 6 UniversityAttivo, non reclutanteLombalgia cronica non specificaGiordania