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Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions in Cerebral Palsy

29. oktober 2018 oppdatert av: Dilara Merve Sarı

Investigation of the Effectiveness of Visual Feedback Training on Upper Extremity Functions

The purpose of the study was to investigate the effectiveness of Cogniboard® Light Trainer, an education device with visual feedback that is added to the Neurodevelopmental Therapy Method (NDT) based upper extremity rehabilitation in children with cerebral palsy, on upper extremity functions such as joint range of motion (ROM), muscle tone, grip strength, pinch strength and functional abilities.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Children with the diagnosis of Cerebral Palsy, aged between 4 and 18 years were included in the study, who were volunteered to participate. The participants were randomly assigned into two groups; A total of 16 sessions of rehabilitation program were applied for 2 days a week for 8 weeks. The treatment programs applied are; Group I: NDT based upper extremity rehabilitation, Group II: NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training. In the cases, pre- and post-treatment spasticity was defined with 'Modified Ashworth Scale'; upper extremity joint range of motion (ROM) with 'goniometer'; grip and pinch strength with 'dynamometer'; hand skills with 'Minnesota Hand Skill Test'; functional abilities with 'Childhood Health Assessment Questionnaire (CHAQ) and functional level with 'Gross Motor Function Classification System (GMFCS)'.

Studietype

Observasjonsmessig

Registrering (Faktiske)

38

Kontakter og plasseringer

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

Studiesteder

    • Eyup
      • Istanbul, Eyup, Tyrkia, 34050
        • Dilbade Education and Rehabilitation Center

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

4 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Participants of the study were selected among the children who applied to Dilbade Education and Rehabilitation Center for rehabilitation.

Simple random sampling method was applied to group selection.

Beskrivelse

Inclusion Criteria:

  • Having the diagnosis of Cerebral Palsy (CP),
  • Aged between 4-18,
  • Having 1+ upper extremity spasticity at max according to the Modified Ashworth Scale (MAS),
  • To be able to cooperate with exercises

Exclusion Criteria:

  • Having mental retardation report,
  • Having congenital deformities,
  • Epilepsy history,
  • Having cardiac, orthopedic, visual and hearing problems,
  • Application of Botulinum Toxin (BOTOX) to the upper extremity in past six month.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Group I
Group I: The control group. Participants in this group received only NDT based upper extremity rehabilitation. Number of the participants were 19.
Group II
Group II: The study group. Participants in this group received NDT based upper extremity rehabilitation + Cogniboard® Light Trainer training. Number of the participants were 19.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Range of motion (ROM)
Tidsramme: Eight weeks
Upper extremity ROM measured with universal goniometer.
Eight weeks
Spasticity
Tidsramme: Eight weeks
Spasticity defined with Modified Ashworth Scale (MAS). The MAS measures resistance during passive soft-tissue stretching. Scoring: 0= normal tone. 1= slight increase in muscle tone, minimal resistance at the end of the range of motion (ROM) when the affected part(s) is moved in flexion or extension. 1+= slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder of the ROM. 2= more marked increase in muscle tone through most of the ROM, but affected part(s) easily moved. 3= considerable increase in muscle tone, passive movement difficult. 4= affected part(s) rigid in flexion or extension.
Eight weeks
Grip and pinch strength
Tidsramme: Eight weeks
Grip and pinch strength measured with dynamometer.
Eight weeks
Hand Skills
Tidsramme: Eight weeks
Hand skills was assessed with Minnesota Dexterity Test (MMDT). MMDT is a standardized test for the evaluation of a subject's ability to move small objects various distances. The score on the test is the total seconds required to complete chosen number of test trials.
Eight weeks
Functional Abilities
Tidsramme: Eight weeks
Functional abilities was assessed with Childhood Health Assessment Questionnaire (CHAQ). CHAQ is used to assess health status in children. It assesses functional ability in 8 domains of physical function (30 items) for children. Each item is scored on a four point scale ranging from 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), 3 (unable to do). The mean score of the eight domains finally makes up the disability index and ranges from 0 (no disability) to 3 (disabled).
Eight weeks
Functional Level
Tidsramme: Eight weeks
Functional level was defined with Gross Motor Function Classification System (GMFCS). GMFCS looks at movements such as sitting, walking and use of mobility devices. It provides a clear description of a child's current gross motor function. Level I can climb stairs without the use of a railing. Level II can walk in most settings and climb stairs holding onto a railing. Level III needs usage of a hand held mobility device, may climb stairs holding onto a railing with assistance. Level IV requires physical assistance or powered mobility in most settings. Level V children are transported in a manuel wheelchair in all settings, they are limited in their ability to maintain antigravity head and trunk postures and control leg and arm movements.
Eight weeks

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studieleder: Tugba Kuru Colak, Marmara University Institute of Health Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

8. januar 2018

Primær fullføring (Faktiske)

21. mai 2018

Studiet fullført (Faktiske)

1. juni 2018

Datoer for studieregistrering

Først innsendt

27. oktober 2018

Først innsendt som oppfylte QC-kriteriene

29. oktober 2018

Først lagt ut (Faktiske)

31. oktober 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. oktober 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2018

Sist bekreftet

1. oktober 2018

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) might be considered to be shared with clinicians studying in the same field one year after the publication of the study.

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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