NCT07664878

Brief Summary

The aim of the project is to create a digital system for cognitive-oriented rehabilitation of the central neuromuscular diseases (CND) with the use of augmented reality (AR) technology in children. Solving the project supports the professional-oriented digital literacy of professionals in rehabilitation institutions in the Czech Republic (CR). With the applied research, the software will be developed for the training of fine and gross motor skills, postural control and walking in the AR environment for children with cerebral palsy and verified in the practice of professionals in rehabilitation. The project aims to modernization and increase of the effectiveness of the work of professionals in rehabilitation institutions in the CR. The project is based on an interdisciplinary approach.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 11, 2026

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.4 years

First QC Date

March 11, 2026

Last Update Submit

June 25, 2026

Conditions

Cerebral Palsy (CP)Augmented Reality Exercise Program

Keywords

cerebral palsymotor function trainingpediatric physiotherapyaugmented reality rehabilitation

Outcome Measures

Primary Outcomes (8)

  • Speed of 10-meter walk test (m/s)

    Speed (m/s): average speed of the walk 10 metres (10MWT)

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Cadence (steps/min)

    Number of half-steps in one minute. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering)

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Support phase (% cycle)

    The average value of the durations of the right and left support phases as percentages of the duration of the gait cycle. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Swing Phase (% Cycle)

    The average value of the durations of the right and left swing phases as percentages of the duration of the gait cycle. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Symmetry index of pelvic tilt

    The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle. Non-pathological subjects show an index greater than 90. The pelvic tilt, is the sagittal component of 3D pelvic movement. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Symmetry index of pelvic obliquity

    The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle. Non-pathological subjects show an index greater than 90. The pelvic tilt, is the frontal component of 3D pelvic movement. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • Symmetry index of pelvic rotation

    The movements of the pelvis in the three principal planes are evaluated using symmetry indexes between the right and left gait cycle. Non-pathological subjects show an index greater than 90. The pelvic tilt, is the transverse component of 3D pelvic movement. Data will be analyzed with the G-Studio software (BTS G-Walk, BTS Bioengineering).

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

  • The Pediatric balance scale (PBS)

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale. The scale consists of 14 balance-related test items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points. Higher total scores suggest that the child has good balance ability.

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

Secondary Outcomes (1)

  • One-Leg Balance (valuated by the time the child is able to maintain the position)

    Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

Study Arms (2)

Control group

ACTIVE COMPARATOR

conventional physical therapy program

Behavioral: Conventional physical therapy

Experimental group

EXPERIMENTAL
Behavioral: AR-based therapyBehavioral: Conventional physical therapy

Interventions

AR-based therapyBEHAVIORAL

The child wore Meta Quest 3 (Meta Platforms, Menlo Park, California, USA) VR/AR goggles during the exercises. Our custom exercise applications were running on the device. They provide brief verbal instructions at the start of each exercise. During the exercise, they also give short cognitive prompts to support focused attention.

Experimental group
Conventional physical therapyBEHAVIORAL

Traditional spa treatment comprising hydrotherapy and physical therapy.

Control groupExperimental group

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Medical diagnosis of spastic hemiparesis or diparesis types cerebral palsy
  • The level of motor skills was at levels I and II according to the Gross Motor Function Classification System (GMFCS)
  • spasticity of grade 2 or less diagnosed with the Modified Ashworth Scale (MAS)
  • Ability to walk at least 10 meters without aids and without the support of a therapist

You may not qualify if:

  • no neurological disease other than CP
  • no visual impairment with exception of short-sightedness
  • Children is not able to follow instructions during testing and training
  • Injection treatment of anti-spastic medication in the last 3 months
  • Lower limb surgery within the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palestra

Prague, Czechia

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. PaedDr. Rudolf Psotta, Ph.D.

Study Record Dates

First Submitted

March 11, 2026

First Posted

June 24, 2026

Study Start

March 1, 2025

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)