- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07664878
AR-Based Motor Rehabilitation for Children With CP (PSYCHO-AR-REH)
25. juni 2026 opdateret af: 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.
Studieoversigt
Status
Tilmelding efter invitation
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Prague, Tjekkiet
- Palestra
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Eksperimentel 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.
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Aktiv komparator: Control group
conventional physical therapy program
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Traditional spa treatment comprising hydrotherapy and physical therapy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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)
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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|
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)
|
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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).
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
|
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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)
|
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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.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
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Change from pre-intervention (first day) to post-intervention (last day of 4-week motor training program)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. marts 2025
Primær færdiggørelse (Anslået)
1. august 2026
Studieafslutning (Anslået)
1. august 2026
Datoer for studieregistrering
Først indsendt
11. marts 2026
Først indsendt, der opfyldte QC-kriterier
17. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TQ01000031
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