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Development of Domiciliary Program on Improving Activities of Daily Living Program for Patients With Stroke

18. marts 2021 opdateret af: National Taiwan University Hospital
The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living (ADL), motor, cognition, perception, sensory, quality of life, and depression for patients with stroke.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Administering ADL and recovery of ADL functions are the primary efficacy indicators in long-term care and the main treatment goals in rehabilitation for patients with stroke. Residential rehabilitation is a direct way to observe patients' living environment and provides feasible ADL treatment plans for patients with stroke living at home or in the community. The purpose of this study was to investigate the effects of the Domiciliary care- Activities of Daily Living program on activities of daily living, motor, cognition, perception, sensory, quality of life, and depression. The eligible participants were recruited and assigned into two groups: ADL home program and control group who received traditional rehabilitation in hospital. The primary outcome measures were the Canadian Occupational Performance Measure, the Barthel Index-based Supplementary Scales, the Frenchay Activities Index, and ADL domain of the Stroke Impact Scale. The secondary outcome measures were the Fugl-Meyer Assessment, the Mini Mental State Examination, the Test of Visual Perceptual Skills-Third Edition, and the Center of Epidemiological Study-Depression.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • Zhongzheng District
      • Taipei, Zhongzheng District, Taiwan, 100
        • National Taiwan University 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

20 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of stroke
  • Aged > 20 years
  • Score 2-4 of the modified Rankin Scale
  • Capability of following instructions
  • Willing to participants to the study

Exclusion Criteria:

  • Diagnoses of dementia and Parkinson's disease
  • Physical limitations because of orthopedics diseases
  • Peripheral nerve injury

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group
ADL training program.
Home-based ADL training.
Ingen indgriben: Control group
Receive rehabilitation program in the hospital.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of the Canadian Occupational Performance Measure
Tidsramme: 6 months
The Canadian Occupational Performance Measure assesses occupational performance. The total score ranges from 1-10. A higher score indicates better occupational performance. Changes of occupational performance will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the Barthel Index-based Supplementary Scales
Tidsramme: 6 months
The Barthel Index-based Supplementary Scales assesses basic activities of daily living. The total score range from 0-58. A higher score indicates better basic activities of daily living. Changes of basic activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the Frenchay Activities Index
Tidsramme: 6 months
The Frenchay Activities Index assesses instrumental activities of daily living. The total score range from 0-45. A higher score indicates better instrumental activities of daily living. Changes of instrumental activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the ADL domain of the Stroke Impact Scale
Tidsramme: 6 months
The ADL domain of the Stroke Impact Scale assess difficulty in performing activities of daily living. The domain score range from 10-50. A higher score indicates less difficulty in performing activities of daily living. Changes of difficulty in performing activities of daily living will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes of the Fugl-Meyer Assessment
Tidsramme: 6 months
The Fugl-Meyer Assessment assesses ability of motor control. The total score range from 0-226. A higher score indicates better ability of motor control. Changes of ability of motor control will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the Mini Mental State Examination
Tidsramme: 6 months
The Mini Mental State Examination assesses general cognitive ability. The total score range from 0-30. A higher score indicates better general cognitive ability. Changes of general cognitive ability will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the Test of Visual Perceptual Skills-Third Edition
Tidsramme: 6 months
The Test of Visual Perceptual Skills-Third Edition assesses visual perception. The total score range from 0-112. A higher score indicates better visual perception. Changes of visual perception will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months
Changes of the Center of Epidemiological Study-Depression
Tidsramme: 6 months
The Center of Epidemiological Study-Depression assesses depression conditions. The total score range from 0-60. A higher score indicates more serious depression conditions. Changes of depression conditions will be assessed at the 6 weeks, 12 weeks, and 6 months.
6 months

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studiestol: Der-Sheng Han, Doctor, National Taiwan University Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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)

15. februar 2018

Primær færdiggørelse (Faktiske)

20. september 2018

Studieafslutning (Faktiske)

20. september 2018

Datoer for studieregistrering

Først indsendt

13. januar 2019

Først indsendt, der opfyldte QC-kriterier

1. februar 2019

Først opslået (Faktiske)

4. februar 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. marts 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. marts 2021

Sidst verificeret

1. marts 2020

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 201712067RIND

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Domiciliary care - Activities of Daily Living

3
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