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AR-Based Motor Rehabilitation for Children With CP (PSYCHO-AR-REH)

25. juni 2026 oppdatert av: Rudolf Psotta, College of Physical Education and Sport PALESTRA

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

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Eksperimentell gruppe
Traditional spa treatment comprising hydrotherapy and physical 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.
Aktiv komparator: Control group
conventional physical therapy program
Traditional spa treatment comprising hydrotherapy and physical therapy.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Speed of 10-meter walk test (m/s)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
One-Leg Balance (valuated by the time the child is able to maintain the position)
Tidsramme: Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
In this task, the child is asked to stand on one leg on a balance board or other unstable surface. Each leg is tested separately. The child must maintain balance for a maximum of 30 seconds. The task is assessed in accordance with the MABC-2 manual.
Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2025

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. august 2026

Datoer for studieregistrering

Først innsendt

11. mars 2026

Først innsendt som oppfylte QC-kriteriene

17. juni 2026

Først lagt ut (Faktiske)

24. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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