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TheraTogs Effects on Balance and Mobility in Cerebral Palsy

30. mai 2026 oppdatert av: Marina Karachanidi, University of West Attica

The Effect of the Dynamic Orthotic Garment TheraTogs on Balance and Functional Mobility of Children and Adolescent With Cerebral Palsy: A Cross-Sectional Clinical Study

Cerebral Palsy (CP) is the most common cause of childhood disability, with an estimated prevalence of 17 million individuals worldwide. Children and adolescents with CP present impaired postural control and balance, negatively affecting their mobility and functional performance. The use of dynamic orthotic garments may contribute to the improvement of postural control, balance, and functional mobility in children and adolescents with CP.

The aim of the present study is to investigate the immediate effect of the dynamic orthotic garment TheraTogs on balance and functional mobility in children and adolescents with CP.

In this cross-sectional pilot study, children and adolescents with CP classified as levels I and II according to the Gross Motor Function Classification System (GMFCS), and with spasticity levels lower than +1 according to the Modified Ashworth Scale, will participate. Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated with the Timed Up and Go (TUG) test and the 10 Meter Walk Test (10MWT). Each assessment will be performed twice by each participant, with and without the TheraTogs dynamic orthotic garment, in random order. Statistical analysis will be conducted using SPSS Statistics V29 software, with the level of significance set at p < 0.05.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

12

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

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

  • Diagnosis of unilateral or bilateral spastic Cerebral Palsy
  • GMFCS level I or II
  • MAS level lower than +1
  • Ability to understand and follow instructions
  • Ability to walk without assistive devices

Exclusion Criteria

  • Use of medications affecting balance
  • Hearing or visual impairments
  • Intellectual disability
  • Botulinum toxin (Botox) injection in the lower limbs within the previous 6 months
  • Severe musculoskeletal deformities
  • Surgery within the previous 6 months
  • Uncontrolled seizures during the previous 6 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: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: NO GARMENT FIRST, THEN GARMENT
Participants will perform three balance and functional mobility assessments, including the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test. Following the initial assessment, participants will wear the orthotic garment and repeat the same assessments.
Enhet: THERATOGS
Theratogs is a dynamic orthotic garment, made of a "breathable", lightweight, self-adhesive Velcro fabric. It provides a gentle passive force for correcting imbalances or alignments through a combined system of the trunk and lower limbs, along with a system of customized external straps. It is worn over the skin under clothing or over a diaper. The patented soft foam material gently grips the user's soft tissues to create biomechanical changes that are essential for positive outcomes. A variety of lengths, back sizes, stiffness diameters, and placement options optimize the therapeutic and orthotic effects.
Eksperimentell: GARMENT FIRST, THEN NO GARMENT
Participants will initially perform the balance and functional mobility assessments while wearing the orthotic garment. After removal of the garment, the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test will be repeated under the same conditions.
Enhet: THERATOGS
Theratogs is a dynamic orthotic garment, made of a "breathable", lightweight, self-adhesive Velcro fabric. It provides a gentle passive force for correcting imbalances or alignments through a combined system of the trunk and lower limbs, along with a system of customized external straps. It is worn over the skin under clothing or over a diaper. The patented soft foam material gently grips the user's soft tissues to create biomechanical changes that are essential for positive outcomes. A variety of lengths, back sizes, stiffness diameters, and placement options optimize the therapeutic and orthotic effects.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
TIMED UP AND GO TEST
Tidsramme: 1 HOUR
The Timed Up and Go (TUG) test evaluates functional mobility. The test requires a chair with armrests and back support, a measuring tape, adhesive tape, and a stopwatch. The time required for the participant to stand up from the chair, walk a distance of three meters (with or without assistive devices), turn around, return, and sit down again is recorded. The TUG test is considered a valid and highly reliable tool (ICC = 0.99) for evaluating functional mobility in children with CP.
1 HOUR
10 Meter Walk Test (10MWT)
Tidsramme: 1 HOUR
The 10 Meter Walk Test (10MWT) evaluates functional mobility by measuring walking speed. Participants walk at their normal pace along a 14-meter walkway with or without assistive devices. A stopwatch is used to record the time required to complete a 10-meter distance, excluding the first and last two meters to allow for acceleration and deceleration. The test demonstrates high test-retest reliability and high correlation with gross motor function in children with CP.
1 HOUR
Pediatric Balance Scale (PBS)
Tidsramme: 1 HOUR
The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale designed to assess functional balance skills in children with mild to moderate motor impairments. The scale consists of 14 balance-related items scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56 and a minimum score of 0 . The PBS has been translated into Greek and is considered a reliable and valid tool for assessing functional balance in children with CP.
1 HOUR

Samarbeidspartnere og etterforskere

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

Sponsor

University of West Attica

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 (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. juni 2026

Studiet fullført (Antatt)

1. juni 2026

Datoer for studieregistrering

Først innsendt

24. mai 2026

Først innsendt som oppfylte QC-kriteriene

24. mai 2026

Først lagt ut (Faktiske)

1. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 30253-12/03/2026 (Annen identifikator: IRB PROTOCOL NUMBER)

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. .

Kliniske studier på Cerebral parese

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