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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-10
SponsorUniversidad Nacional de San Agustin de Arequipa

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Feseability and User SatisfactionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of eligible participants who complete all scheduled sessions

This will assess the feasibility of the intervention.

Time frame
Immediately after the intervention.
2

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.

Time frame
Immediately after the intervention

Secondary outcomes

1

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

Time frame
Baseline (T-1), pre-intervention (T0) and immediately after the intervention (T1)
2

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.

Time frame
Baseline, pre-intervention and immediately after the intervention
3

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.

Time frame
Baseline, pre-intervention, and immediately after the intervention
4

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.

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

Other outcomes

Sponsors and contacts

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