Cerebral Palsy (CP)Rehametrics-CPNCT07612332
Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy
A study testing non inmersive VR System in people with Cerebral Palsy (CP), run by Universidad Nacional de San Agustin de Arequipa at 1 site in Peru.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- non inmersive VR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePeru
- Study dates
- 1 Jun 2026to 21 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Peru1 site
Pedro P. Diaz
Arequipa, Arequipa, 54
Elizabeth Vidal, Phd, +51986451412, evidald@unsa.edu.pe
Eveling Castro, Phd, +51987740628, ecastro@unsa.edu.pe
About this study
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
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
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- non inmersive VR System
- Keywords
- cerebral palsy, virtual reality, rehabilitation, gait, balance, gross motor function, pediatric, non-immersive, serious game
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non inmersive VR SystemDevice
Also called Rehametrics
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
| Study group | Role | What they receive |
|---|---|---|
| Feseability and User Satisfaction | Experimental | Participant will use Rehametrics plataform for training balance and gait Receives: Device: non inmersive VR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible participants who complete all scheduled sessions
This will assess the feasibility of the intervention.
Measured: Immediately after the intervention.
User Satisfaction Evaluation Questionnaire (USEQ)
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.
Measured: Immediately after the intervention
Secondary outcomes (6)
Functional Mobility - Timed Up and Go (TUG)
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
Measured: Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)
Gross Motor Function - GMFM-88
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.
Measured: Baseline, pre-intervention and immediately after the intervention
Balance - Pediatric Balance Scale (PBS)
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.
Measured: Baseline, pre-intervention, and immediately after the intervention
Participation - Pittsburgh Rehabilitation Participation Scale (PRPS)
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.
Measured: immediately after the procedure (end-of-session rating by the physiotherapist).
User Experience Questionnaire - UEQ
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
Measured: Immediately after the Intervention
Rehametrics performance scores
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.
Measured: Immediately after the procedure (session 1-9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion21 Nov 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de San Agustin de Arequipa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Vidal, Universidad Nacional de San Agustin de Arequipa
- Investigators
- Emilia Biffi, Phd, Principal investigator, Scientific Institute IRCCS E. Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612332
- Sponsor's protocol ID
- PI_27_2024_UNSA
- Other IDs
- PI_27_2024
- Acronym
- Rehametrics-CP
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 10960935Rosenbaum 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.
PubMed 17370477Ravi 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.
PubMed 28109566Monge 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.
PubMed 22341675Parsons TD, Gaggioli A, Riva G. Virtual Reality for Research in Social Neuroscience. Brain Sci. 2017 Apr 16;7(4):42. doi: 10.3390/brainsci7040042.
PubMed 28420150Novak 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.
PubMed 24958005Nossa 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.
PubMed 36294467Nicolini-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.
PubMed 24142322Moreau 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.
PubMed 27313240Lo 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.
PubMed 39159449Levac 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.
PubMed 21415229Lenze 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.
PubMed 15031821Laver 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.
PubMed 29156493Holden 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.
PubMed 15971970Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PubMed 18183564
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07612332
- Acronym / sponsor ID
- Rehametrics-CP / PI_27_2024_UNSA
- Conditions
- Cerebral Palsy (CP)
- Keywords
- cerebral palsy, virtual reality, rehabilitation, gait, balance, gross motor function, pediatric, non-immersive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Nacional de San Agustin de ArequipaUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 21 Nov 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feseability and User Satisfaction | Experimental | Device: non inmersive VR SystemParticipant will use Rehametrics plataform for training balance and gait |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non inmersive VR SystemAlso: RehametricsThe 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 | Device | Feseability and User Satisfaction |
Primary outcome
Proportion of eligible participants who complete all scheduled sessions
Time frame: Immediately after the intervention.
This will assess the feasibility of the intervention.
User Satisfaction Evaluation Questionnaire (USEQ)
Time frame: 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.
6 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Background: PubMed 10960935Russell 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.
- Background: PubMed 17370477Rosenbaum 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.
- Background: PubMed 28109566Ravi 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.
- Background: PubMed 22341675Monge 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.
- Background: PubMed 28420150Parsons TD, Gaggioli A, Riva G. Virtual Reality for Research in Social Neuroscience. Brain Sci. 2017 Apr 16;7(4):42. doi: 10.3390/brainsci7040042.
- Background: PubMed 24958005Novak 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.
- Background: PubMed 36294467Nossa 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.
- Background: PubMed 24142322Nicolini-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.
- Background: PubMed 27313240Moreau 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.
- Background: PubMed 39159449Lo 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.
- Background: PubMed 21415229Levac 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.
- Background: PubMed 15031821Lenze 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.
- Individual participant dataSharing planned: No. 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.
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Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emilia Biffi, Phd principal investigator
Scientific Institute IRCCS E. Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non inmersive VR System in people with Cerebral Palsy (CP), run by Universidad Nacional de San Agustin de Arequipa at 1 site in Peru.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Peru. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Vidal, Phd (+51986451412, evidald@unsa.edu.pe), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible participants who complete all scheduled sessions (time frame: Immediately after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07612332, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.