- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07664878
AR-Based Motor Rehabilitation for Children With CP (PSYCHO-AR-REH)
25 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Aanmelden op uitnodiging
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Prague, Tsjechië
- Palestra
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimentele groep
|
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.
|
|
Actieve vergelijker: Control group
conventional physical therapy program
|
Traditional spa treatment comprising hydrotherapy and physical therapy.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Speed of 10-meter walk test (m/s)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
One-Leg Balance (valuated by the time the child is able to maintain the position)
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 maart 2025
Primaire voltooiing (Geschat)
1 augustus 2026
Studie voltooiing (Geschat)
1 augustus 2026
Studieregistratiedata
Eerst ingediend
11 maart 2026
Eerst ingediend dat voldeed aan de QC-criteria
17 juni 2026
Eerst geplaatst (Werkelijk)
24 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
25 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TQ01000031
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .