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Enrolling by invitation NCT07664878

AR-Based Motor Rehabilitation for Children With CP

No phase Interventional Cerebral Palsy (CP) Augmented Reality Exercise Program

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AR-based therapy, Conventional physical therapy.
Who it may be relevant to
Registry conditions: Cerebral Palsy (CP), Augmented Reality Exercise Program. Basic parameters: 6 years — 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Digitalization of Rehabilitation Care for Children With Motor Disorders Using Augmented Reality Technologies

Overview

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.

Interventions

  • Behavioral AR-based therapy
    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.
  • Behavioral Conventional physical therapy
    Traditional spa treatment comprising hydrotherapy and physical therapy.

Primary outcome measures

  • Speed of 10-meter walk test (m/s) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Cadence (steps/min) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Support phase (% cycle) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Swing Phase (% Cycle) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic tilt [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic obliquity [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • Symmetry index of pelvic rotation [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
  • The Pediatric balance scale (PBS) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]
Secondary outcome measures (1)
  • One-Leg Balance (valuated by the time the child is able to maintain the position) [Time frame: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Czechia · 1 center
  • Palestra — Prague

Identifiers

NCT: NCT07664878 · TQ01000031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗