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

NCT07612332 | Not Yet Recruiting

• 2 other identifiers: PI_27_2024_UNSAPI_27_2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Cerebral Palsy (CP)

Keywords

cerebral palsy; virtual reality; rehabilitation; gait; balance; gross motor function; pediatric; non-immersive; serious game

Outcome Measures

Primary Outcomes (2)

• Proportion of eligible participants who complete all scheduled sessions

  This will assess the feasibility of the intervention.

  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.

  Immediately after the intervention

Secondary Outcomes (6)

• Functional Mobility - Timed Up and Go (TUG)

  Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)

• Gross Motor Function - GMFM-88

  Baseline, pre-intervention and immediately after the intervention

• Balance - Pediatric Balance Scale (PBS)

  Baseline, pre-intervention, and immediately after the intervention

• Participation - Pittsburgh Rehabilitation Participation Scale (PRPS)

  immediately after the procedure (end-of-session rating by the physiotherapist).

• User Experience Questionnaire - UEQ

  Immediately after the Intervention

Study Arms (1)

Feseability and User Satisfaction

EXPERIMENTAL

Participant will use Rehametrics plataform for training balance and gait

Device: non inmersive VR System

Interventions

non inmersive VR System DEVICE

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

Also known as: Rehametrics

Feseability and User Satisfaction

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de San Agustin de Arequipa: lead

Study Sites (1)

Pedro P. Diaz

Arequipa, Arequipa, 54, Peru

Location

Related Publications (26)

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MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Emilia Biffi, Phd

  Scientific Institute IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Vidal, Phd

CONTACT

+51986451412; evidald@unsa.edu.pe

Eveling Castro, Phd

CONTACT

+51987 740 628; ecastro@unsa.edu.pe

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 21, 2026
• Study Completion (Estimated): November 21, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)