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Effects of Attention Training on Children

4. maj 2020 opdateret af: Ru-Lan Hsieh, Taipei Medical University

Therapeutic Effects of Interactive Attention Training on Children With Attention Deficit Hyperactivity Disorder

Using a double-blind, randomized controlled design to investigate the therapeutic effects of interactive attention training for children with Attention Deficit Hyperactivity Disorder who are receiving conventional rehabilitation programs due to developmental delay.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 30 children with Attention Deficit Hyperactivity Disorder conducting conventional rehabilitation programs well be enrolled.

The children are randomized into two groups, including study group with conventional rehabilitation programs and interactive attention training: 2 times per week, 15 min per session, with a total of 24 sessions in 3 months; and control group with conventional rehabilitation programs without interactive attention training.

Therapeutic effects, including working memory, attention, functional performance, physical function, health-related quality of life will be evaluated at baseline, and 3 months and 6 months after the intervention.

The evaluator and children will be blinded to the group's allocation during the whole course of the intervention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

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

4 år til 8 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • children with a diagnosis of Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient 70 or greater

Exclusion Criteria:

  • age less than 4 or greater than 8 of children diagnosed with Attention Deficit Hyperactivity Disorder with developmental delay, under regular conventional rehabilitation programs, Intelligence quotient less than 70

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Study group
3 months of interactive attention training programs, 2 times per week, 15 min per session, a total of 24 sessions, with conventional rehabilitation programs
Andet: using interactive attention training system
using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
Ingen indgriben: Control group
3 months of conventional rehabilitation programs without interactive attention training programs

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
changes of symptoms of attention deficit hyperactivity disorder
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome
score assessed by Swanson, Nolan and Pelham questionnaire
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a better outcome

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
changes of sensory integration
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Sensory Profile
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of visual motor integration
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Beery-Buktenica Visual Motor Integration Test
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of intelligence
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Wechsler Intelligence Scale for Children
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of functional performance
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Pediatric Outcome Data Collection Instrument
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of health-related quality of life
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
score assessed by Pediatric Quality of Life Inventory
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of family impact
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Child Health Questionnaire, parent form 28
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of walking speed
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
walking speed
time change from baseline to 3 months of treatment, and 3 months after treatment
changes of chair climbing speed
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
stairs climbing speed
time change from baseline to 3 months of treatment, and 3 months after treatment
changes of balance
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
one leg standing time
time change from baseline to 3 months of treatment, and 3 months after treatment
changes of coordination
Tidsramme: score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
Berg Balance Scale
score change from baseline to 3 months of treatment, and 3 months after treatment, lower scores mean a worse outcome
changes of balance and coordination
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
timed up and go test
time change from baseline to 3 months of treatment, and 3 months after treatment
changes of physical performance
Tidsramme: time change from baseline to 3 months of treatment, and 3 months after treatment
5 time sit to stand test
time change from baseline to 3 months of treatment, and 3 months after treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taipei Medical University

Efterforskere

  • Ledende efterforsker: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital

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 (Forventet)

1. maj 2020

Primær færdiggørelse (Forventet)

31. december 2020

Studieafslutning (Forventet)

31. december 2020

Datoer for studieregistrering

Først indsendt

29. april 2020

Først indsendt, der opfyldte QC-kriterier

4. maj 2020

Først opslået (Faktiske)

5. maj 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. maj 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2020

Sidst verificeret

1. maj 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2019SKHADR038

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Attention Deficit Hyperactivity Disorder

Kliniske forsøg med using interactive attention training system

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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